Table 1 Study measures
Construct assessed | Data collection instrument | Time of collection |
Primary outcome measure | Patient-reported outcomes | |
Pain | Pain subscale of the KOOS | 0, 3, 6, 12 and 24 months |
Secondary outcome measures | Data collection instrument | Time of collection |
Patient-reported outcomes | ||
Symptoms, ADL, QOL, sport & recreation | Four individual subscales of the KOOS | 0, 3, 6, 12 and 24 months |
Pain intensity, sites, & interference with functioning | Brief Pain Inventory | 0, 3, 6, 12 and 24 months |
Health-related quality of life | EuroQol-5D-5L | 0, 3, 6, 12 and 24 months |
Ability to forget about the knee | Forgotten Joint Score | 0, 3, 6, 12 and 24 months |
Pain catastrophizing | Pain Catastrophizing Scale | 0, 3, 6, 12 and 24 months |
Anchor measures of satisfaction | Patient acceptable symptom state | 0, 3, 6, 12 and 24 months |
Treatment failure | 3, 6, 12 and 24 months | |
Global perceived effect | 3, 6, 12 and 24 months | |
Objective measures | ||
Functional lower extremity test | 30-s sit-to-stand test | 0, 3, 6, 12 and 24 months |
Adverse events | Treatment records, hospital records, questionnaire | Continuously – 12 monts |
Other measures | Time of collection | |
Patient-reported outcomes | ||
Sleep quality | Pittsburgh Sleep Quality Index | 0, 3, 6, 12 and 24 months |
Mood states | Hospital Anxiety and Depression Scale | 0, 3, 6, 12 and 24 months |
Pain-related fear of movement | Fear-Avoidance Belief Questionnaire | 0, 3, 6, 12 and 24 months |
Health locus of control | Health Locus of Control Scale | 0, 3, 12 and 24 months |
Self-reported level of physical activity level and readiness for change | HUNT2, Stages of Change physical activity | 0, 3, 6, 12 and 24 months |
Digital health literacy | The eHealth Literacy Questionnaire | 0 and 6 months |
Health literacy | The International Health Literacy Population survey Questionnaire 2019–2021 | 0 and 6 months |
Comorbidity | Self-Administered Comorbidity Questionnaire | 0 months |
Objective measures | ||
Time in active position/number of steps | ActiGraph Professional Single Axis accelerometer | 0, 6, 12 and 24 months |
Physical function -walking | 40-m fast paced walk test | 0, 3, 6, 12 and 24 months |
Lower body strength and balance | Stair climb test | 0, 3, 6, 12 and 24 months |
Body mass index | Weight from baseline to follow-up | 0, 3, 6, 12 and 24 months |
Radiological assessments | Weightbearing AP, lateral view, Rosenberg view and long leg weightbearing AP view (HKA) | 0 and 12 months |
Registry-based data | ||
Use of health care resources | KUHR-system | 0 to 24 months |
Norwegian Patient Registry | 0 to 24 months | |
FD trygd social security data base | 0 to 24 months | |
Norwegian Prescription Database | 0 to 24 months | |
The Norwegian Arthroplasty registry | 0 to 24 months | |