Table 1 Self-complete postal questionnaire. Conceptual domains, operational definitions and empirical measures

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