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

From: The epidemiology of polymyalgia rheumatica in primary care: a research protocol

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
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
BL, 12FU, 24FU
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
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
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
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
1 BL
Obesity BMI at time of questionnaire Height (m/ft)
Weight (kg/st, lb)
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
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
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
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
Physiotherapy Yes/No and Received Yes/No 2
Referral to secondary care   2
  1. 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