Table 2.
Summary of measures to be collected
| Data collection instrument and scale | Time points | |
|---|---|---|
| Primary outcome measure: | ||
| Number of patients classified as OMERACT/OARSI-responders in each group. | The responder classification is a composite index reported as a single variable (responder yes/no), based on change after treatment in pain, function and patient’s global assessment. | t2, t3 |
| Secondary outcomes: | ||
| Hand pain at rest | Numeric rating scale: 0–10, 0 is no pain | t1, t2, t3 |
| Physical function | The Functional Index for Hand OsteoArthritis is a summary score (ranging from 0 to 30) of 10 items, each scored on a four-point scale, 0 = possible without difficulty | t1, t2, t3 |
| Patient’s global assessment | Numeric rating scale: 0–10, 0 is no disease activity | t1, t2, t3 |
| Activity performance | In the Measure of Activity Performance of the Hand, as a mean of 18 standardised activities, (rating scale 1–4, 1 is no problems) | t1, t2, t3 |
| Maximal grip strength | In kg by the JAMAR dynamometer | t1, t2, |
| Painful finger joints | Examination by a trained OT of presence of pain yes/no in CMC1, MCP, PIP and DIP-joints in both hands | t1, t2 |
| Pain in activity at each hand (measured following measurement of grip strength) | Numeric rating scale: 0–10, 0 is no pain | t1, t2, |
| Hand stiffness | Numeric rating scale: 0–10, 0 is no stiffness | t1, t2, t3 |
| Health related quality of life | EuroQoL 5D-5 L - health-related quality of life contains five items scored at a five level scale, (“no problems” to “unable to do”) and a visual analogue scale ranging from 0 and 100. 0 corresponds to “the worst health you can imagine”. | |
| Satisfaction with care | The PasOpp questionnaire contains eleven statements with a 5-point scoring scale ranging from “not at all” to “very much”, and one statement concerning waiting time with a 4-point scoring scale ranging from “not at all” to “very long”. | t2, |
t1 = baseline, t2 = 6 months after baseline, t3 = 12 months after baseline. OT = occupational therapist. CMC1 = carpometacarpal joint of the thumb, MCP = metacarpal joint, PIP = proximal interphalangeal, DIP = distal interphalangeal, IP = interphalangeal joint of the thumb