Table 2.
Questionnaire items
| Conceptual domain | Operational definition | Empirical measure | Number of items | Time point |
|---|---|---|---|---|
|
Section A: About Gout | ||||
| Gout frequency |
No. of attacks in the last 12 months/since last contact |
Numerical rating scale 0- ≥ 5 |
1 |
All |
| Age at diagnosis |
Age in years |
Numerical free text box |
1 |
BL |
| Acute attack of gout |
Acute episode at time of questionnaire |
Yes/No |
1 |
All |
| Allopurinol |
Reported use of allopurinol |
Yes/No |
1 |
All |
| Current daily dose of allopurinol |
Nine daily dose options: 50 mg-900 mg |
1 |
All |
|
|
Section B: How gout affects your life | ||||
| Gout concern, wellbeing, productivity, convenience and satisfaction |
Gout Impact Scale
[11] |
5-item Likert scale |
18 |
All |
| Illness perception |
Modified Illness perception questionnaire
[12] |
5-item Likert scale |
4 |
BL, 12 months, 36 months |
|
Section C: General Health | ||||
| Physical function |
SF36 Physical function sub-scale (PF10)
[13] |
3-item Likert scale |
10 |
All |
| Health Assessment Questionnaire Disability Index
[14] |
4-item Likert scale |
17 |
All |
|
| Co-morbidities |
Diabetes mellitus, Renal failure, renal calculi, Cerebrovascular accident, Transient ischaemic attacks, ischaemic heart disease, hyperlipidaemia |
Yes/No |
9 |
BL |
|
Section D: How you feel | ||||
| Depression |
Patient health questionnaire (PHQ 9)
[15] |
4 point Likert scale |
16 |
BL, 12 months, 36 months |
| Anxiety |
Generalised anxiety disorder questionnaire (GAD)
[16] |
|||
|
Section E: Foot and other joint problems | ||||
| Hallux valgus |
Self-completed line drawings
[17] |
5 line-drawings for each foot depicting increasing severity of hallux valgus |
2 |
BL, 12 months, 36 months |
| Pain |
Pain in the hands, hips, knees and feet in the last year |
Yes/No |
4 |
BL, 12 months, 36 months |
| Location of body pain in last 4 weeks |
Self-completed body manikin
[18,19] |
1 |
BL, 12 months, 36 months |
|
| Foot pain |
Foot pain, aching, stiffness in last month
[20] |
Frequency on 5-point Likert scale |
1 |
BL, 12 months, 36 months |
| Foot pain location |
Location of foot pain in last four weeks |
Self-completed foot manikin
[21] |
1 |
BL, 12 months, 36 months |
| Foot function |
Manchester Foot Pain and Disability Index
[22] |
Frequency on 3-point likert scale |
17 |
BL, 12 months, 36 months |
| Consultation for foot problems |
Consultation with GP, physiotherapy, podiatry, in last 12 months/since last contact |
Yes/No |
4 |
BL, 12 months, 36 months |
|
Section F: Work | ||||
| Occupational characteristics |
Current employment status |
11-response options |
1 |
BL, 12 months, 36 months |
| Work absence during last 6 months due to joint/back problems |
Yes/No |
1 |
BL, 12 months, 36 months |
|
| Ability to do usual job |
5-response options |
1 |
BL, 12 months, 36 months |
|
|
Section G: Demographic/socioeconomic characteristics | ||||
| Date of birth |
Date of birth |
Date of birth |
1 |
BL |
| Gender |
Gender |
Male/Female |
1 |
BL |
| Anthropometric characteristics |
Height |
Meters or feet/inches |
1 |
All |
| Weight |
Kilogram or stones/pounds |
1 |
All |
|
| Marital status |
Marital status |
6-response options |
1 |
BL |
| Living alone |
Living alone |
Yes/No |
1 |
BL |
| Adequacy of income |
Adequacy of income |
4-response options |
1 |
BL |
| Education |
Higher education |
Yes/No |
1 |
BL |
| Ethnicity |
Ethnicity |
6-response options |
1 |
BL |
| Life-style-characteristics | Frequency of alcohol consumption |
6-response options |
1 |
BL |
| Weekly amount of beer/spirits/wine consumed |
Free-text |
1 |
BL |
|
| Smoking status | 3-response options | 1 | BL | |