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Table 2 Outcome measures and timetable

From: Hydroxychloroquine effectiveness in reducing symptoms of hand osteoarthritis (HERO): study protocol for a randomized controlled trial

  Month(s)
  0 3 6 12
Primary outcome     
Average overall hand pain severity over the previous 2 weeks (0 to 10 NRS)
Secondary outcomes     
Imaging assessments     
• Bilateral hand X-ray   
• Ultrasound synovitis score    
Clinical assessments     
• Grip strength  
• Joint count  
Self-reported questionnaires     
• AUSCAN[37, 38] (pain, stiffness and function) – five-point Likert scale
• 11-point NRS and VAS scales[39] for:
°Average overall hand pain severity / pain in the most painful joint over the past 2 weeks / 2 days     
• NRS scales for:
°Global disease activity / average thumb pain / average pain in other joints over the past 2days     
°Severity rating of participant nominated main functional problem over the past 2 days     
°Satisfaction with hand function over the past 2 days     
°Hand pain, aching, or stiffness over the past month (no days to all days     
• Globala improvement in hand problem/hand pain/ability to use hands  
• Pain elsewhere (pain manikin)    
• Duration of hand pain over the past 12 months (<7 days, 1 to 4 weeks, >1 month, <3 months, >3 months)    
• Onset of hand pain (last 12 months, 1 to 5 years, 5 to 10 years, 10 years or more)    
• Quality of life: SF12v2 and OAQoL[40]  
• EuroQol EQ-5D[41, 42]  
• Depression and anxiety: HADS[43]  
Demographics and medical history    
Concomitant medicationb
Adverse eventsb  
  1. aA six-point Likert scale: completely better, much better, better, no change, worse, much worse. bAlso recorded at 1 month and 9 months. AUSCAN, Australian Canadian osteoarthritis hand index; HADS, Hospital Anxiety and Depression Scale; NRS, numerical rating scale; OAQoL, Osteoarthritis Quality of Life Scale; VAS, visual analogue scale.