Baseline | 2 months | 6 months | 12 months | ||
---|---|---|---|---|---|
Likely primary outcome measure for main trial | |||||
Physical function | SF-36v2 Physical Component Summary13 http://www.sf-36.org/ (the higher the score the better the physical health) | ✓ | ✓ | ✓ | ✓ |
Secondary outcome measures | |||||
Overall change in condition | Global Assessment of Change since baseline—single question | ✗ | ✓ | ✓ | ✓ |
Mental health | SF-36v2 Mental Component Summary13 http://www.sf-36.org/ (the higher the score the better the mental health) | ✓ | ✓ | ✓ | ✓ |
Quality of life | EuroQol EQ-5D-5L http://www.euroqol.org14 (the higher the score the better the quality of life) | ✓ | ✓ | ✓ | ✓ |
Self-efficacy | Pain Self-Efficacy Questionnaire15 (10-item scale: 0=not at all confident, 60=completely confident despite pain) | ✓ | ✓ | ✓ | ✓ |
Understanding of condition | General Practice Assessment Questionnaire enablement subscale16 (very well, unsure, not very well) | ✓ | ✓ | ✓ | ✗ |
Experience of consultations | General Practice Assessment Questionnaire communication16 (Based on 5 items represented as a percentage of the maximum possible score 100) | ✓ | ✓ | ✓ | ✗ |
Convenience of services | Single question (0–10 Numerical Rating Scale: 0=not at all convenient, 10=very convenient) | ✓ | ✓ | ✓ | ✗ |
Satisfaction with services | Single question (0–10 Numerical Rating Scale: 0=not satisfied, 10=very satisfied) | ✓ | ✓ | ✓ | ✗ |
Baseline measures | |||||
Demographics | Gender, date of birth, ethnicity, education, health literacy, employment status, socioeconomic status (recent paid job title, housing) | ✓ | ✗ | ✗ | ✗ |
Baseline risk of persistent problems | STarT Musc tool (draft tool developed at Keele University to identify patients' risk of persistent pain and disability) | ✓ | ✗ | ✗ | ✗ |
Pain location | Body manikin | ✓ | ✗ | ✗ | ✗ |
Pain duration | Single question about duration of pain | ✓ | ✗ | ✗ | ✗ |
Comorbidities | Single question | ✓ | ✗ | ✗ | ✗ |
Economic outcomes | |||||
Further healthcare usage | Consultations, investigations, procedures, admissions, over-the-counter medications | ✗ | ✗ | ✓ | ✓ |
Work absence | Single question (number of days) | ✓ | ✓ | ✓ | ✓ |
Presenteeism | Single work performance question (0–10 Numerical Rating Scale: 0=not at all affected, 10=unable to do my job) | ✓ | ✓ | ✓ | ✓ |
SF-36, 36-item Short Form Health Survey.