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Table 1 Content of the Baseline and 12-week follow-up questionnaires

From: The effects of arthritis gloves on people with Rheumatoid Arthritis or Inflammatory Arthritis with hand pain: a study protocol for a multi-centre randomised controlled trial (the A-GLOVES trial)

Concept Measurement method Details 0-wks 12-wks
Demographic and Condition Information Date of birth    
  Gender    
  Time since RA or IA symptom onset    
  Time since RA or IA diagnosis    
  Employment status    
  Marital status    
  Living status (alone; or with family/significant others)    
  Medication regimen (i.e. what drugs do they take for their arthritis);    
  Whether received a steroid injection/oral steroid in the last 6 weeks    
  Hand dominance (i.e. whether they consider this to be right, left or both).    
Primary outcome Hand Pain during activity 0-10 (0 = no pain/10 = severe pain) point numeric rating scale of hand pain in the dominant hand during the day [21]
Secondary outcomes Hand Pain 0-10 (0 = no pain/10 = severe pain)
a) during a typical day during activities in the last week in the non-dominant hand;
b) when resting- separately for the dominant and non-dominant hands; and
c) at night –separately for the dominant and non-dominant hands.
  Stiffness Measured separately for the dominant and non-dominant hands:
a) Patient self-reported duration of early morning stiffness affecting the hands (hours/min)
b) 0-10 point numeric rating scale of hand stiffness (no (0) and severe (10) hand stiffness)
  Self-reported hand condition a five point rating scale of very severe/severe/moderate/good/very good.
Hand Function The Measure of Activity Performance of the Hand (MAPHAND) [22, 23] a self-reported measure of 18 items of performing daily activities with the hands
  The Michigan Hand Outcomes Questionnaire (MHQ) [24, 25] assesses right and left hands separately: physical status of the hand (movement, strength, sensation: 5 items); daily activities performed with the hands/arms (5 right and left; 7 bilateral); impact of their condition on their normal activities (5 items); pain frequency, severity and impact (5 items); perceived appearance of their hands (4 items); satisfaction with hand abilities (6 items)
Disability The Health Assessment Questionnaire [26] 24 items of daily function
Economic analysis EQ5D-3 L [27, 28] 5-items Scale (Mobility; Self-care; Usual activities; Pain/Discomfort; Anxiety/Depression
  Your use of NHS and social services a) Any planned hospital overnight stays in the last 3 months
b) List of planned admissions
  Your use of hospital out-patient appointments a) Any planned hospital outpatient appointments lasting 4 h or less in the last 3 months
b) If yes, department, speciality and number of appointments
  Your use of day hospital appointments a) Any day or hospital outpatient lasting more than 4 h but not overnight during the last 3 months
b) If yes, department, speciality and number of appointments
  Your use of accident and emergency services a) Any A&E attendance in the last 3 months
b) If yes, the number of visits did not lead to hospital admission
c) Were admitted into a hospital as an in-patient from the A&E
d) If yes, department, reason for admission, where and when admitted
  Your use of primary and community based health services a) Use of services such as GP, Practice nurse, Nurse, Counsellor in the last 3 months
b) If yes, number of visits to each
  Your use of primary and community based health services a) Use of services such as, occupational therapy, Physio, Care worker, Home help, Social worker, Other in the last 3 months
b) If yes, number of visits to each
Medication Current medication for RA/IA   
  Any steroid injection/oral steroids started in the last 12 weeks Yes/No  
  If yes, the date of the injection/started taking oral steroids DD/MM/YY  
Health Status Your own health state today Measured by a 0-100 vertical scale (0 = worst imaginable state & 100 = best imaginable health state)  
Additional outcomes Any other upper limb occupational therapy or physiotherapy treatment received in the last 12 weeks Type of treatment received  
  Whether purchased or obtained from elsewhere, any other “arthritis” gloves. Yes/No  
  If yes, what type these were   
  How their hands are in comparison to 12 weeks ago, i.e. before receiving gloves (much better/better/no change/worse/much worse)  
  Concurrent use of any resting, wrist, finger or thumb splints   
  Adherence to glove wear During the day and at night for right/left hand gloves; average time worn at night/during the day; average number of days per week gloves have been worn  
  Whether participants considered gloves provided any benefit Yes/No  
  Whether they will continue to wear the gloves provided Yes/No  
  If they considered the gloves of any benefit, what were these   
  Any problems encountered when wearing gloves Freetext