Table 4.

Elements to document the content validity of a ClinRO assessment intended to provide evidence of treatment benefit.

Definition of the concept of interest for measurement of the ClinRO assessment reading, rating, or global impression (i.e., conceptual framework of the instrument). For indirect measures of how patients survive, feel, or function, the documented relationship between the concept of interest and the treatment benefit should be established a priori. The following elements should be specific to the clinical trial context of use: Summary of literature review Research strategy relevant to the concept of interest Published and nonpublished data Summary of concept elicitation methods and results, including evidence of saturation from concept elicitation with clinicians Protocol, interview guide, analysis plan Transcripts Origin and derivation of concepts measured in the ClinRO assessment Rationale for omitting concepts Understandability of the instructions to implement or perform the assessment and to score or interpret the outcomes (research with clinicians) Protocol, interview guide, analysis plan Transcripts Understandability of patient instructions, if any are associated with assessment Protocol, interview guide, analysis plan for research with patients Transcripts Comprehensiveness of the ClinRO assessment qualitative and quantitative methods and results Protocol, analysis plan Rasch or IRT on item locations if data available Differential item functioning if applicable Integrity of the ClinRO assessment in other targeted languages Translatability assessment Cultural adaptation methods Integrity of the measure across modes of administration Demonstration of measurement properties User manual Key references

ClinRO, clinician-reported outcome; IRT, item response theory.