Table 4 Validation checklist for the PROMIS physical function questionnaire
Validation category | Validation element |
|---|---|
Conceptual model | • Has the PRO construct to be measured been specifically defined? |
• Has the intended respondent population been described? | |
• Does the conceptual model address whether a single construct/scale or multiple subscales are expected? | |
Content validity | • Is there evidence that members of the intended respondent population were involved in the PRO measure’s development? |
• Is there evidence that content experts were involved in the PRO measure’s development? | |
• Is there a description of the methodology by which items/questions were determined (e.g., focus groups, interviews)? | |
Reliability | • Is there evidence that the PRO measure’s reliability was tested (e.g., test-retest, internal consistency)? |
• Are reported indices of reliability adequate (e.g., ideal: r ≥ 0.80; adequate: r ≥ 0.70; or otherwise justified)? | |
Construct validity | • Is there reported quantitative justification that single scale or multiple subscales exist in the PRO measure (e.g., factor analysis, item response theory)? |
• Are there findings supporting expected associations with existing PRO measures or with other relevant data? | |
• Are there findings supporting expected differences in scores between relevant known groups? | |
• Is the PRO measure intended to measure change over time? If yes, is there evidence of both test-retest reliability and responsiveness to change? | |
Scoring and interpretation | • Is there documentation how to score the PRO measure (e.g., scoring method such as summing or an algorithm)? |
• Has a plan for managing and/or interpreting missing responses been described (i.e., how to score incomplete surveys)? | |
• Is information provided about how to interpret the PRO measures scores [e.g., scaling/anchors, (what high and low scores represent), normative data, and/or definition of severity (mild or severe)]? | |
Respondent burden and presentation | • Is the time to complete reported and reasonable? Or, if it is not reported, is the number of questions appropriate for the intended application? |
• Is there a description of the literacy level of the PRO measure? | |
• Is the entire PRO measure available for public viewing (e.g., published with citation, or information provided about how to access a copy)? |