Table 1.

COSMIN checklist items

COSMIN items
Item 1: Is a clear description provided of the construct to be measured?
Item 2: Is the origin of the construct clear: was a theory, conceptual framework or disease model used or clear rationale provided to define the construct to be measured?
Item 3: Is a clear description provided of the target population for which the PRO measure (PROM) was developed?
Item 4: Is a clear description provided of the context of use?
Item 5: Was the PROM development study performed in a sample representing the target population for which the PROM was developed?
Item 6: Was an appropriate qualitative data collection method used to identify relevant items for a new PROM?
Finally, we added a further item to the checklist (derived from FDA criteria): Item 6a: Were appropriate literature searches conducted to identify relevant items for a new PROM?