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Table 5 Tertiary outcome measures

From: Self management, joint protection and exercises in hand osteoarthritis: a randomised controlled trial with cost effectiveness analyses

Outcome

Measurement Scale

Time points

Demographic variables

  

Age

Years

HS, 0Q, 3, 6Q, 12, +

Gender

Female/Male

HS, 0Q, 3, 6Q, 12, +

Marital status

Married/Separated/divorced/widowed/cohabiting/single

HS

Employment status

Working full time/working part time/working full time in the home/unemployed or seeking work/not working due to ill health or disability/student/retired

HS

Social class [65]

Higher managerial/Higher professional/Lower managerial or professional/Intermediate occupations/Self employed/Lower supervisory or technical/Semi-routine/Routine

HS, 0NA

Age when left school

Years

HS

Leave school to go to full-time education or university

Yes/No

HS

Age when finished full time education

Years

HS

Gained qualifications through study as an adult

Yes/No

HS

Ethnic origin

White UK or European/AfroCaribbean/Chinese/Asian

/African/Other

HS

Height

Feet and inches or centimetres

HS

Weight

Stones and lbs or kilograms

HS

Measures to define trial inclusion/exclusion

  

Hand pain in the last year

Yes/No

HS

Pain, aching or stiffness in your hands in the last month [30]

No days/Few days/Some days/Most days/All days

HS, 0Q, 0NA, 3, 6NA, 12

Seen OT or PT for hand problem in last 6-months

No/Right hand only/Left hand only/Both hands

HS, 0NA1

Injured hands badly enough to see a doctor in last 6 months

No/Right hand only/Left hand only/Both hands

HS, 0NA1, 6NA

Had a hand operation in the last 6 months

No/Right hand only/Left hand only/Both hands

HS, 0NA1, 6NA

Joint injection (fingers, thumbs or wrist) in the last 6 months

No/Right hand only/Left hand only/Both hands

HS, 0NA1

Clinical red flags (e.g. swollen painful hot hands or recent trauma to the hands)

Yes/No

0NA, 6NA

Clinical assessment for hand swelling, nodes, enlargement or deformity

Yes/No for joints required to apply the ACR criteria for hand OA (ref)

0NA

Characteristics of hand problem

  

Handedness

Right/Left/Both

HS, 0NA, 6NA

Hand problems in the last year

Yes/No

HS

Hand pain location in the last year

Right/Left/Both

HS, 0NA2, 6NA2

Hand pain manikin [43]

Hand area shaded to represent pain

0Q, 3, 6Q, 12

Hand that gives most problem

Right/Left/No difference

HS, 0NA, 6NA

Number of days with hand pain in the last year [66]

Less than 7 days/1 to 4 weeks/> 1 month and < 3 months/3-months or more

HS

Hand pain severity in the last month

NRS: 0-10 (no pain to pain as bad as could be)

0Q

Bothersomeness of hand problems (adapted from [67])

Not at all/slightly/moderately/very much/Extremely

0Q, 3, 6Q, 12

Thumb pain during activity in the last month

Yes/No

0NA, 3, 6NA, 12

Ability to make a fist [68]

Right: yes/no/unable; Left: yes/no/unable

0NA, 6NA

Length of time with a hand problem

HS-years

0NA-Separate response for right and left hand

< 12 months/1 to 5 yrs/5 to 10 yrs/10+ yrs

HS, 0NA

Previous hand surgery

Operation details, which hand, timing (< 1 yr ago/1 to 5yrs ago/5 to 10yrs ago/10+ yrs ago)

0NA, 6NA3

Previous hand injury

Injury details, which hand, timing (< 1 yr ago/1 to 5yrs ago/5 to 10yrs ago/10+ yrs ago)

0NA, 6NA3

Past or present job involved excessive use of hands

Yes/No

HS

Past or present hobbies or pastimes involved excessive use of hands

Yes/No

HS

Global assessment of change in hand pain since baseline [41]

Completely recovered/much better/better/no change/worse/much worse

3, 6Q, 12

Global assessment of change in ability to use hands since baseline [41]

Completely recovered/much better/better/no change/worse/much worse

3, 6Q, 12

Body pain and shoulder function

  

Pain elsewhere (body manikin)

Body area shaded to represent pain lasting for a day or longer in the last 4 weeks

HS, 3, 6Q, 12

Ability to put hands behind head [68]

Right: yes/no/unable; Left: yes/no/unable

0NA, 6NA

Perception, impact and quality of life

  

Illness perceptions

Subset of questions from the illness perceptions questionnaire revised (IPQ-R) [45, 51]

HS, 0Q, 3, 6Q, 12

Participation restriction (selected questions from [46])

All the time/most of the time/some of the time/A little of the

0Q, 3, 6Q, 12

- Self-care needs met as and when wanted

time/None of the time

 

- Home looked after as and when wanted

  

- Belongings looked after as and when wanted

  

Hand problems make you feel frustrated in the last month [45]

All days/most days/some days/few days/no days

0Q, 3, 6Q, 12

Adaptation behaviours

 

0NA, 6NA

- Use gadgets

Yes/No to each question

 

- Help from another person

  

- Avoidance

  

- Find a different way of doing something

  

- Stopping/reducing activities

  

- Things take longer

  

- Other (please state)

  

Quality of life: EuroQol-EQ5-D [47, 48]

(-0.59-1)

0Q, 3, 6Q, 12

Intervention evaluation

  

Satisfaction with care received for hand problem

Very satisfied/Quite satisfied/no opinion/not very satisfied/not at all satisfied

3, 6Q, 12

Treatment sessions: Number of appointments

Too many/About right/Not enough/I did not attend any appointments

3

Treatment sessions: Length of each visit

Too long/About right/Too short/I did not attend any appointments

3

Hand exercise frequency [69]

Never/Once a week/Twice a week/Three times a week/Four times a week/Five times a week/Six times a week/Once every day/Twice every day

6Q, 12

Hand exercise frequency in last week [52]

Never/Almost never/Sometimes/Fairly often/Very often/Always

0Q, 3, 6Q, 12

Hand exercise duration [69]

< Five minutes/5-10 minutes/10-15 minutes/15-30 minutes/30 minutes+/I don't do hand exercises

6Q, 12

Behaviour change in last week: energy conservation/fatigue [52]

(1-6) i.e. average of 5 items each rated as: Never/Almost never/Sometimes/Fairly often/Very often/Always

0Q, 3, 6Q, 12

- Regular breaks

  

- Breaking up tasks

  

- Pacing of activities

- Swapping between light and heavy tasks

  

- Maintaining good posture whilst sitting, standing, lifting objects or moving about

  

Behaviour change in last week: joint protection use [52]

(1-6) i.e. average of 5 items each rated as: Never/Almost

0Q, 3, 6Q, 12

- Use two hands to carry things

never/Sometimes/Fairly often/Very often/Always

 

- Avoid gripping or pinching things tightly

  

- Change the way everyday activities are completed

  

- Use gadgets/labour-saving devices

  

- Use stronger, larger joints

  

Behaviour change in last week: carry on working through the pain when doing everyday activities [52]

Never/Almost never/Sometimes/Fairly often/Very often/Always

0Q, 3, 6Q, 12

Health care use and co-interventions

  

Self-report

Self-help remedies, contact with NHS and private healthcare, over the counter medicines, use of hand splints

HS, 0NA, 6Q, 6NA, 12

GP consultation download

Number of follow-up visits to the GP, prescription of medication including NSAIDs and referral for other treatment such as surgery

Continually collected data

Nurse audit questions

  

Did the participant un-blind you during the assessment?

Yes/No

6NA

If yes, what did the participant say and could it have been avoided?

Text

6NA

If yes, what treatment arm do you think the patient is randomised to

Leaflet and advice/Had OT, but not sure which OT intervention/Had OT, joint protection/Had OT, hand exercises/Had OT, joint protection and hand exercises

6NA

  1. NRS = Numerical rating scale; OT = occupational therapist; PT = Physiotherapist; HS = Baseline Health Survey; 0Q = Baseline Questionnaire; 0NA = Baseline nurse assessment; 3 = 3-month questionnaire; 6Q = 6-month questionnaire; 6NA = 6-month nurse assessment; 12 = 12-month questionnaire; + = included in minimum data collection; 1 = time frame last month; 2 = refers to current hand problem; 3 = time frame last 6 months.