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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