Variables | Patients/Parents | Other Stakeholders | Average of Sums 5 | ||||
---|---|---|---|---|---|---|---|
Inner | Middle | Sum | Inner | Middle | Sum | ||
Mandatory domains (inner circle/core set) | |||||||
Pain1 | 88 | 67 | 77 | ||||
Joint inflammatory signs/active joints1 | 50 | 89 | 70 | ||||
Side effects/adverse events2 | 63 | 58 | 60 | ||||
Activity limitation/physical function3 | 76 | 18 | 94 | 79 | 19 | 98 | 96 |
Patient’s perception of disease/overall well-being4 | 32 | 56 | 88 | 66 | 25 | 91 | 90 |
Important but optional domains (middle circle) | |||||||
Joint damage | 71 | 25 | 96 | 41 | 50 | 91 | 93 |
Laboratory signs of inflammation (acute-phase reactants) | 53 | 37 | 90 | 82 | 16 | 96 | 93 |
Eye inflammation | 47 | 47 | 94 | 62 | 36 | 98 | 96 |
Inflammatory signs outside joints/eyes | 46 | 44 | 90 | 66 | 34 | 100 | 95 |
Physician’s perception of disease activity | 32 | 52 | 84 | 83 | 14 | 97 | 90 |
Stiffness | 46 | 48 | 94 | 46 | 44 | 91 | 92 |
Growth and maturation | 28 | 54 | 82 | 23 | 64 | 87 | 85 |
Participation restriction | 30 | 56 | 86 | 24 | 55 | 78 | 82 |
Imaging signs of inflammation | 25 | 58 | 84 | 25 | 55 | 79 | 81 |
Physical activity (exercise) | 16 | 73 | 89 | 3 | 62 | 65 | 77 |
Fatigue | 42 | 52 | 94 | 5 | 54 | 58 | 76 |
Effect on emotional function, mood, cognition | 42 | 47 | 89 | 8 | 45 | 54 | 71 |
Research agenda (outer circle) | |||||||
Coping with illness | 20 | 61 | 81 | 5 | 49 | 54 | 67 |
Healthcare use | 24 | 53 | 77 | 4 | 36 | 40 | 58 |
Sleep | 8 | 67 | 75 | 0 | 40 | 40 | 57 |
Effect on social relationships | 13 | 56 | 68 | 1 | 32 | 33 | 51 |
Personal factors | 14 | 56 | 70 | 1 | 30 | 31 | 51 |
↵1 Domains voted into inner circle with round 1 of Delphi.
↵2 Side effects/adverse events is a mandatory domain for all clinical trials per OMERACT Handbook.
↵3 Domain placement rules for Delphi round 3 based on percent votes for inner circle and middle circle: if average of inner circle votes for both stakeholder groups > 70% recommend inner circle. If sum of inner circle plus middle circle votes > 70% for both stakeholder groups (but average of inner circle votes alone is not > 70%), recommend middle circle. If sum of inner circle and middle circle votes > 70% for only 1 stakeholder group, but average > 70%, then consider middle circle. If sum of inner circle and middle circle votes > 70% for only 1 or none of the stakeholder groups, and average < 70%, then recommend outer circle.
↵4 Inclusion of patient’s perception of disease/overall well-being in inner circle based on OMERACT workshop voting does not follow suggested domain placement rules. See text.
↵5 “Average of sums” is average of inner circle plus middle circle votes for both stakeholder groups from Delphi round 3. The sums do not add to 100 because of exclusion of the votes for outer circle from presentation in the table. OMERACT: Outcome Measures in Rheumatology.