Table 1.

ISPOR Good Measurement Practices Checklist for COAs: ClinRO Assessment Development and Evaluation.

✓ Consider and define the context of use for the ClinRO assessment(s)

✓ Choose the intended treatment benefit on how patients feel, function, or survive that the ClinRO assessment is meant to reflect

✓ Identify the concept(s) of interest to be measured by the ClinRO assessment(s)

✓ Consider and evaluate the relationship between treatment benefit and the concept of interest assessed by the ClinRO assessment

✓ Document the content validity of the ClinRO assessment

✓ Evaluate other measurement properties of the ClinRO assessment once content validity is established

✓ Establish place of the ClinRO assessment to define study end points and study objectives and place in the hierarchy of end points

✓ Establish the interpretability of trial results

✓ Evaluate operational considerations for implementation of ClinRO assessments in clinical trials

ClinRO, clinician-reported outcome; COA, clinical outcome assessment.