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Table 5 Adherence, cost effectiveness and other measures

From: Does occupational therapy reduce the need for surgery in carpometacarpal osteoarthritis? Protocol for a randomized controlled trial

  Data collection instrument and scale Time points
Adherence:
 Hand exercises (intervention group only) Treatment diary, recording of days with exercising, length of exercising in minutes t3
 Orthoses (intervention group only) Treatment diary, recording of days and nights with using orthosis and length of use (day and night) in hours and minutes t3
 Possession and use of assistive devices Questionnaire with 20 specified devices with possibility of adding more, possession of each device yes/no, if yes; use regularly, use only when in pain, do not use t1, t3, t4, t5
Cost-effectiveness:
 Utility European Quality of Life Scale (EQ-5D), which comprises the EQ-5D index and the EQ-5D visual analogue scale t1, t3, t4, t5
 Treatment sessions Number and length of each treatment session t1, t2, t3, t4, t5
 Orthoses Number and type of orthoses t1, t2, t3, t4, t5
 Hand exercises Number and type of exercise material t1, t2, t3, t4, t5
 Assistive devices Number and type of device t1, t2, t3, t4, t5
 Sick leave and absence from work Number of days t3, t4, t5
 Use of medication Name and dosage of medicine t1, t3, t4, t5
 Health care utilisation Number of visits and/or hospital stays t3, t4, t5
 Medical or technical equipment Type and costs of equipment purchased t3, t4, t5
Other measures
 Age Years t1
 Gender Female/male t1
 Marital status Living alone or not t1
 Employment status Working full time/ working part time/ not working/ student/ working full time in the home/ unemployed or seeking work /age retired/ disability pension/ sick leave t1
 Level of education 7–10 years of education, 10–12 years of education, 13–15 years of education, more than 15 years of education t1
 Hand dominance Right or left t1
 Other diseases/previous injuries that may negatively impact hand function Yes/no, if yes-what kind of disease/injury t1
 Previous hand surgery Yes/no, if yes-right hand, left hand or both hands t1
 Referred for surgery in Right hand, left hand or both hands t1
 Main reason for wanting surgery Description of the main reason t1
 Previously received hand therapy due to HOA Yes/no, if yes-what kind of therapy t1
 Motivation for surgery Numeric rating scale: 0–10, 0 is no motivation t1
 Joints with osteoarthritis (as diagnosed by physician or finger joints with bony enlargement) Marked by the OT on a map with joints of the body t1
 Degree of CMC1-HOA Conventional radiography of both hands, graded according to the Kellgren-Lawrence method, with grades from 0 to 4, (grade 4 indicating large osteophytes, severe sclerosis and narrowing joint space)  
 Degree of radial trapeziometacarpal subluxation Conventional radiography of both hands, graded as subluxation ratio using a digital calculation calliper  
 Presence of erosive HOA Conventional radiography of both hands, ≥1 joint with erosion = erosive OA.  
 Comorbidity Presence of 16 diseases/health problems (yes/no) t1
 Comfort with use of assistive devices Numeric rating scale: 0–10, 0 is very uncomfortable t1, t3, t4, t5
  1. t1 = baseline, t2* = two weeks after baseline (control group only), t3 = 4 months after baseline, t4 = 18 months after baseline, t5 = 24 months after baseline, CMC1 Carpometacarpal joint of the thumb, HOA Hand osteoarthritis