Classification of outcome measurement instruments into subdomains and COMET outcomes
| No | COMET domain outcome | No of 86 RCTs reporting COMET outcomes (%) | Subdomain outcome | No of 54 OMIs into subdomain outcomes (%) | OMI (n=54) |
| 1 | Function | 85 (98.8) | Function ADL ROM Symptoms Measure of walking Global rating of change | 10 (18.5) 3 (5.6) 1 (1.9) 1 (1.9) 3 (5.6) 3 (5.6) | JOA/improvement of JOA/mJOA/ODI/mRMDQ/RMDQ/ ZCQ/SSS/self-made lumbar function evaluation scale/physical function, role-physical, vitality of SF-36 ADL subscale of JOA, ODI or RMDQ Rang of lumbar spine extension Self-made symptoms rating scale SPWT/walking capacity/Pain-free walking distance Responder rates/Global Rating of Change Scale/general health of SF-36 |
| 2 | Pain | 84 (97.7) | Pain | 6 (11.1) | VAS/NRS/UAB-PBS/pain subscale of JOA/pain subscale of SSS/bodily pain subscale of SF-36 |
| 3 | AEs | 19 (22.1) | AE | 1 (1.9) | AE |
| 4 | Physiological | 11 (12.8) | Inflammatory markers Haemorheological marker Immunological markers Physiological markers Radiographic changes | 8 (14.8) 3 (5.6) 4 (7.4) 3 (5.6) 1 (1.9) | IL-6\IL-1B\TNF\CRP\IL-1\IL-4\IL-10\ESR Blood viscosity/plasma viscosity/RBC haematocrit Changes in T lymphocyte subsets Hepatic and renal function tests/Serum endothelin Parameters of CT |
| 5 | CM indictor | 5 (5.8) | CM meridian/CM Zheng | 2 (3.7) | Near-infrared imaging system on meridian CM Zheng scores |
| 6 | Mental health | 4 (4.7) | Mental health | 2 (3.7) | HADS/ mental health subscales of SF-36 |
| 7 | Satisfaction | 4 (4.7) | Satisfaction index | 1 (1.9) | Satisfaction subscale of SSS |
| 8 | Quality of life | 3 (3.5) | Quality of life | 1 (1.9) | SF-36 |
| 9 | Psychosocial | 3 (3.5) | Psychosocial | 1 (1.9) | Social function, role-emotional subscales of SF-36 |
| 10 | Compliance | 1 (1.2) | Adherence and attrition | 1 (1.9) | Treatment Adherence index |
| 11 | Resource use | 0 (0) | Resource use | 0 (0) | NR |
| 12 | Mortality | 0 (0) | Mortality | 0 (0) | NR |
| 13 | Infection | 0 (0) | Infection | 0 (0) | NR |
ADL, activities of daily living; AE, adverse event; CM, Chinese medicine; COMET, Core Outcome Measures in Effectiveness Trials; CRP, C reactive protein; HADS, Hospital Anxiety and Depression Scale; JOA, Japanese Orthopedic Association Score; mJOA, modified JOA; mRMDQ, modified Roland Morris Disability Questionnaire; NR, not reported; NRS, Numerical Rating Scale; ODI, Oswestry Disability Index; OMI, Outcome Measurement Instruments; RBC, red blood cell; RMDQ, Roland Morris Disability Questionnaire; ROM, range of movement; SF-36, 6-Item Short Form Survey; SPWT, Self-Paced Walk Test; SSS, Spinal Stenosis Scale; TNF, tumour necrosis factor; UAB-PBS, University of Alabama at Birmingham- Pain Behavior Scale; VAS, Visual Analogue Scale; ZCQ, Zurich Claudication Questionnaire.