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 | ||||
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 | Â | Â | ||
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 | Â | 2 | ||
Other |