Table 4 Outcome measures
Characteristics & confounders | Description and instrument | Data source | Sample | Collection points |
|---|---|---|---|---|
Patient’s characteristics | Date of birth, gender, ethnicity, BMI (height, weight), site (s) of OA diagnosis, date of first OA diagnosis, labour situation (working, retired, unemployed, in rehabilitation status) | SAQ, IDB | IG, CO | t0, t3, t6, t12, t24 |
Primary outcome measure | Clinical Outcomes | |||
Pain | WOMAC Index 3.1 German (11-box NRS): subscale pain | SAQ | IG, CO | t0, t3 |
Function | WOMAC Index 3.1 German (11-box NRS): subscale physical functioning | SAQ | IG, CO | t0, t3 |
Secondary outcome measures | Clinical Outcomes | IG, CO | ||
Stiffness, disease specific impairment | WOMAC Index 3.1 German (11-box NRS): subscale stiffness, overall score | SAQ | IG, CO | t0, t3, t6, t12, t24 |
Pain, physical function | WOMAC Index 3.1 German (11-box NRS): subscale pain, subscale physical function | SAQ | IG, CO | t6, t12, t24 |
Health related quality of life | VR-12 incl. VR-6D utility index (4-week-time-slot) | SAQ | IG, CO | t0, t3, t6, t12, t24 |
General Self-Efficacy | General self-efficacy scale (GSE) | SAQ | IG, CO | t0, t3, t6, t12, t24 |
Response to exercise | Omeract-OARSI Set of Responder Criteria: composite score with minimum absolute and relative change levels for pain or pain & function | SAQ | IG, CO | t0, t3, t6, t12, t24 |
Physical activity status | Habitual physical and sports activity status | SAQ | IG, CO | t0, t3, t6, t12, t24 |
Time to surgery | Endpoint “elective joint replacement” | IDB | IG, CO | t0, t3, t6, t12, t24 |
Patient satisfaction | ||||
Modified version of the ZUF-8 Questionnaire to assess patient satisfaction | SAQ | IG | t3 | |
Economic data | ||||
Unspecific and specific (OA-related) health care costs | Out-patient costs, hospital costs, costs related to drugs, adjuvants and physical modalities, rehabilitation costs, sick-pay | IDB | IG, CO | tm24, tm18, tm12, tm6 t0, t3, t6, t12, t24 |
Unspecific/specific (OA related) periods of disability | Days of disability (overall and related to OA) | IDB | IG, CO | tm24, tm18, tm12, tm6 t0, t3, t6, t12, t24 |
Intervention related costs | Costs for human and physical resources/session | IDB | IG | t3, t6, t12, t24 |
Adherence to exercise | ||||
Training adherence | Summarized number of attended training sessions according to training log | SAQ | IG | t3 |
Safety evaluation | ||||
Adverse events and side-effects | Summarized number and details of adverse events and side-effects according to training log | SAQ | IG | t3 |