Self-reported outcome measurement development |
Concept elicitation: sample size (evaluated based on COSMIN guidelines) [20, 22] |
Cognitive interview study: number of patients per item |
Comprehensiveness: number of patients per item |
Content validity |
Relevance (patients): number of patients per item |
Comprehensiveness (patient): number of patients per item |
Comprehensibility (patient): number of patients per item |
Relevance (professionals): number of professionals per item |
Structural validity |
Exploratory factor analysis (EFA) |
Confirmatory factor analysis (CFA) |
Internal consistency |
Continuous scores: Cronbach’s alpha or omega |
Dichotomous scores: Cronbach’s alpha or KR-20 |
Item response theory (IRT)-based scores: SE (θ) or reliability coefficient |
Reliability |
Continuous scores: intraclass correlation coefficient (ICC) |
Dichotomous/nominal/ordinal scores: kappa, weighted kappa (ordinal scores) |
Cross-cultural validity |
Whether the PROM shows similar structural validity and reliability when validated in another cultural context or translated to another language |