Outcome | Measurement Scale | Time points |
---|---|---|
Demographic variables | Â | Â |
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 | Â | Â |
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 | Â | Â |
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 | Â | Â |
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 | Â | Â |
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 | Â |
- Home looked after as and when wanted | Â | Â |
- Belongings looked after as and when wanted | Â | Â |
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 | Â | 0NA, 6NA |
- Use gadgets | Yes/No to each question | Â |
- Help from another person | Â | Â |
- Avoidance | Â | Â |
- Find a different way of doing something | Â | Â |
- Stopping/reducing activities | Â | Â |
- Things take longer | Â | Â |
- Other (please state) | Â | Â |
(-0.59-1) | 0Q, 3, 6Q, 12 | |
Intervention evaluation | Â | Â |
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 | Â | Â |
- Breaking up tasks | Â | Â |
- Pacing of activities - Swapping between light and heavy tasks | Â | Â |
- Maintaining good posture whilst sitting, standing, lifting objects or moving about | Â | Â |
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 | Â |
- Avoid gripping or pinching things tightly | Â | Â |
- Change the way everyday activities are completed | Â | Â |
- Use gadgets/labour-saving devices | Â | Â |
- Use stronger, larger joints | Â | Â |
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 | Â | Â |
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 | Â | Â |
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 |