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Table 2 Summary of measures to be collected

From: Task shifting in the care for patients with hand osteoarthritis. Protocol for a randomized controlled non-inferiority trial

  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,
  1. 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