Recommended end points and measures for PROs in SCD
| Outcome/End point . | Recommended measurement/tool(s) . |
|---|---|
| Pain | |
| Intensity | For patients at least 8 y of age, an 11-point NRS or appropriately reproduced and administered VAS |
| Interference/impact | PROMIS Pain Interference measures for studies of adult, pediatric, or mixed age groups |
| ASCQ-ME Pain Impact for adults or the Brief Pain Impact for adults | |
| PedsQL Pain Impact and Pain and Hurt for children | |
| Behavior | PROMIS Pain Behavior domain for children and adults |
| Affect | |
| Depression/negative emotional impact | PedsQL SCD Module Emotions measure for children |
| ASCQ-ME Emotional Impact measure for adults | |
| PROMIS Depression and Anxiety measures for more general measures of negative affect, particularly when mixed age samples are used | |
| Fatigue | PROMIS or PedsQL Fatigue measures in children |
| PROMIS Fatigue measure in adults | |
| Function | |
| Emotional/social, physical, cognitive domains | Relevant domains of the PROMIS and ASCQ-ME in adults and PROMIS and PedsQL in children to measure emotional/social, physical, and cognitive function PRO domains |
| The Canadian Occupational Performance Measure may be used to measure functional capacity that integrates self-report and expert interview | |
| Occupational status | One item in PhenX for assessment of employment status and the more detailed WHO’s Health and Work Performance Questionnaire to assess multiple factors related to work performance |
| Self-efficacy | Sickle Cell Efficiency Scale to measure self-efficacy in adolescents and adults with SCD |
| Outcome/End point . | Recommended measurement/tool(s) . |
|---|---|
| Pain | |
| Intensity | For patients at least 8 y of age, an 11-point NRS or appropriately reproduced and administered VAS |
| Interference/impact | PROMIS Pain Interference measures for studies of adult, pediatric, or mixed age groups |
| ASCQ-ME Pain Impact for adults or the Brief Pain Impact for adults | |
| PedsQL Pain Impact and Pain and Hurt for children | |
| Behavior | PROMIS Pain Behavior domain for children and adults |
| Affect | |
| Depression/negative emotional impact | PedsQL SCD Module Emotions measure for children |
| ASCQ-ME Emotional Impact measure for adults | |
| PROMIS Depression and Anxiety measures for more general measures of negative affect, particularly when mixed age samples are used | |
| Fatigue | PROMIS or PedsQL Fatigue measures in children |
| PROMIS Fatigue measure in adults | |
| Function | |
| Emotional/social, physical, cognitive domains | Relevant domains of the PROMIS and ASCQ-ME in adults and PROMIS and PedsQL in children to measure emotional/social, physical, and cognitive function PRO domains |
| The Canadian Occupational Performance Measure may be used to measure functional capacity that integrates self-report and expert interview | |
| Occupational status | One item in PhenX for assessment of employment status and the more detailed WHO’s Health and Work Performance Questionnaire to assess multiple factors related to work performance |
| Self-efficacy | Sickle Cell Efficiency Scale to measure self-efficacy in adolescents and adults with SCD |