Table 1.
Self-complete postal questionnaire. Conceptual domains, operational definitions and empirical measures
| Conceptual domain | Operational definition | Empirical measure | Number of items | Time point |
|---|---|---|---|---|
|
PMR symptoms | ||||
| PMR-related pain |
Level of pain attributed to PMR at time of questionnaire |
Numerical rating scale (0–10) of pain intensity |
1 |
ALL |
| PMR-related stiffness |
Level of stiffness attributed to PMR at time of questionnaire |
Numerical rating scale (0–10) of stiffness |
1 |
ALL |
| Pain and stiffness locations |
Pain shaded in hips and shoulders to define PMR. |
Manikin (Figure 2) |
2 |
ALL |
| Daily stiffness pattern |
Periods of day with stiffness in the past week |
None/Morning/Lunchtime/ Afternoon/Early evening/ Late evening/During the night |
1 |
ALL |
| Morning stiffness |
Duration of stiffness from time of waking in the past week |
None/1 to 15 minutes/16 to 45 minutes/ 46 minutes to an hour/More than an hour |
1 |
ALL |
| Delay in patient consultation |
Symptom chronicity at presentation to GP |
Less than a week/1 to 2 weeks/ 2 to 4 weeks/More than 4 weeks |
1 |
BL |
| Delay in GP diagnosis |
Number of consultations with GP before receiving diagnosis |
1/2/3/4 or more |
1 |
BL |
| Shoulder movement |
Ability to raise both arms above head at time of questionnaire |
Yes/No |
1 |
ALL |
| Patient perceived recovery |
Patient’s self-perceived rating of recovery |
6 category scale (Completely recovered through to Much worse) |
1 |
1FU, 4FU, 8FU, 12FU, 18FU, 24FU |
|
PMR Medications | ||||
| Cortico steroid dose |
Current daily dose of prednisolone |
Free text |
1 |
ALL |
| Other medication use |
Reported use of (i) Paracetamol, (ii) paracetamol + codeine, (iii) non-steroidal anti-inflammatories, (iv) strong analgesics, (v) gastro-intestinal protection, (vi) calcium + vitamin D, (vii) osteoporosis treatment, (viii) alternative therapies, (ix) anti-depressants, (x) other |
Yes/No (free text for Other) |
10 |
BL |
|
General health and other medical problems | ||||
| General health |
Self-rated health at time of questionnaire Global health rating |
EuroQoL [16] Excellent/Very good/ Good/Fair/Poor |
5 1 |
BL, 12FU, 24FU ALL |
| Falls |
Falls in previous 12 months |
Yes/No |
1 |
BL, 12FU, 24FU |
| Osteoporosis |
Ever fractured (i) hip, (ii) wrist, (iii) spine/vertebrae, (iv) other |
Yes/No |
4 |
BL, 12FU, 24FU |
| PMR exclusion symptoms |
Reports of recent (i) Sudden headache, (ii) Tender scalp, (iii) Disturbed/double vision, (iv) Jaw claudication, (v) Temperature, (vi) Appetite loss, (vii) Unintentional weight loss, (viii) Joint swelling, (ix) Other |
Yes/No (free text for Other) |
9 |
BL |
| Dyspepsia |
Bothersomeness of dyspepsia symptoms (ulcer, wind, indigestion, heartburn) at time of questionnaire Seeking of healthcare of dyspepsia symptoms (if present) |
Not at all bothered/Bothered a little/ Bothered a lot Did not seek help/ Went to GP/Went to hospital/ Other type of care |
1 1 |
4FU, 12FU, 24FU 4FU, 12FU, 24FU |
|
Daily activities | ||||
| Activities of daily living |
Performance in daily activities in past week |
Modified Health Assessment Questionnaire [17] adapted to UK English [18] |
8 |
ALL |
|
Fatigue and sleep | ||||
| Fatigue |
Fatigue symptoms in past week |
Functional Assessment of Chronic Illness Therapy-Fatigue (Version 4) [19] |
13 |
BL, 1FU, 12FU, 24FU |
| Sleep |
Insomnia symptoms in past 2 weeks (including Diagnostic and Statistical Manual of Mental Disorders insomnia definition) |
Insomnia Severity Index [20] |
7 |
BL, 1FU, 12FU, 24FU |
|
Anxiety and depression | ||||
| Generalised anxiety disorder |
Anxiety symptoms in past two weeks |
Generalized Anxiety Disorder-7 [21] |
7 |
BL, 1FU, 12FU, 24FU |
| Depression |
Depression symptoms in past two weeks |
PHQ-8 [22] |
8 |
BL, 1FU, 12FU, 24FU |
|
Socio-demographics | ||||
| Age |
Age at diagnosis |
Date of birth |
1 |
ALL |
| Sex |
Sex |
Male/Female |
1 |
ALL |
| Ethnicity |
Ethnicity |
White/Mixed, multiple ethnic groups/ Asian, Asian British/Black, African, Caribbean, Black British/Other |
1 |
BL |
| Employment status |
Employment status at time of questionnaire |
Employed/ Unemployed, seeking work/ House-wife/Retired/Not working due to ill health/Other |
1 |
BL, 1FU, 4FU, 12FU, 18FU, 24FU |
| Work situation |
Level of work at time of questionnaire (in those in reporting being employed as their employment status) |
Doing usual job/ Working fewer hours/ Paid sick leave/Paid annual leave, holiday/ Doing lighter duties/Unpaid leave |
1 |
BL, 10FU, 4FU, 12FU, 18FU, 24FU |
| Socioeconomic status |
Occupational class based on (i) current or (ii) most recent job title |
Job title – categorised as manual/ non-manual according to SOC 2010 [23] |
1 |
BL |
|
Lifestyle | ||||
| Smoking |
Smoking status at time of questionnaire |
Never/Previous/Current |
1 |
BL |
| Alcohol |
Frequency of drinking at time of questionnaire |
Daily or almost daily/ 3 or 4 times a week/ Once or twice a week/ 1 to 3 times a month/ Special occasions only/Never |
1 |
BL |
| Obesity |
BMI at time of questionnaire |
Height (m/ft) Weight (kg/st, lb) |
1 1 |
BL BL, 12FU, 24FU |
|
Relationships and social support | ||||
| Living arrangement |
Live alone |
Yes/No |
1 |
BL, 24FU |
| Marital status |
Marital status at time of questionnaire |
Married/Separated/Divorced/Widowed/ Cohabiting/Single |
1 |
BL, 12FU, 24FU |
| PMR interference with sexual relationships |
Interference with intimate and sexual relationships |
Not applicable/Not at all/ Little bit/ Moderately/Quite a bit/Extremely (adapted from [24]) |
1 |
BL, 12FU, 24FU |
| Social support |
Availability of instrumental support Availability of emotional support |
Yes/No/No need [25] Yes/No/No need |
1 1 |
BL, 12FU, 24FU |
|
Views on PMR and information on the condition | ||||
| Origin PMR |
Cause of PMR |
Free text |
1 |
BL |
| Information regarding PMR |
Information given by GP GP information from GP useful Desire for more information from GP Searched elsewhere for information |
Yes/No Yes/No Yes/No Yes/No |
1 1 1 1 |
BL |
| Worries regarding PMR |
Flares |
Yes/No |
1 |
24FU |
| Medications |
Yes/No |
1 |
||
| Reducing medications |
Yes/No |
1 |
||
| Side-effects of medication |
Yes/No |
1 |
||
| Yes/No |
1 |
|||
| Long-term consequences of PMR |
Yes/No |
1 |
||
| Other |
|
|
||
| Potentially useful for PMR patients in the future | Information |
Yes/No and Received Yes/No |
2 |
24FU |
| Medications |
Yes/No and Received Yes/No |
2 |
||
| Alternative medications |
Yes/No and Received Yes/No |
2 |
||
| Yes/No and Received Yes/No |
2 |
|||
| Complementary therapies |
Yes/No and Received Yes/No Yes/No and Received Yes/No |
2 |
||
| Physiotherapy |
Yes/No and Received Yes/No |
2 |
||
| Referral to secondary care |
2 | |||
| Other | ||||
ALL = All follow-ups; BL = Baseline; 1FU = 1-month follow-up; 4FU = 4-month follow-up; 8FU = 8-month follow-up; 12FU = 12-month follow-up; 18FU = 18-month follow-up; 24FU = 24-month follow-up