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

Table 2 Outcome measures and timetable

	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
• Global^a 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 medication^b	✓	✓	✓	✓
Adverse events^b		✓	✓	✓

^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.

ISSN: 1745-6215