Table 1

Classification of outcome measurement instruments into subdomains and COMET outcomes

NoCOMET domain outcomeNo of 86 RCTs reporting COMET outcomes (%)Subdomain outcomeNo of 54 OMIs into subdomain outcomes (%)OMI (n=54)
1Function85 (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
2Pain84 (97.7)Pain6 (11.1)VAS/NRS/UAB-PBS/pain subscale of JOA/pain subscale of SSS/bodily pain subscale of SF-36
3AEs19 (22.1)AE1 (1.9)AE
4Physiological11 (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
5CM indictor5 (5.8)CM meridian/CM Zheng2 (3.7)Near-infrared imaging system on meridian
CM Zheng scores
6Mental health4 (4.7)Mental health2 (3.7)HADS/ mental health subscales of SF-36
7Satisfaction4 (4.7)Satisfaction index1 (1.9)Satisfaction subscale of SSS
8Quality of life3 (3.5)Quality of life1 (1.9)SF-36
9Psychosocial3 (3.5)Psychosocial1 (1.9)Social function, role-emotional subscales of SF-36
10Compliance1 (1.2)Adherence and attrition1 (1.9)Treatment Adherence index
11Resource use0 (0)Resource use0 (0)NR
12Mortality0 (0)Mortality0 (0)NR
13Infection0 (0)Infection0 (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.