Table ES. Sensitivity and specificity estimates for MRI, CT and X-ray in patients with LBP Suspected indication Type Study ID, Quality a Study type (number of included studies) Source Sensit. (%) Specif (%) AUROC LR+ LR- DOR Lumbar disc herniation CT Moranjkic (2011), Fair 1 study, (direct comparison with MRI) Study 1 92.3 85.7 0.624 N/A N/A N/A Van Rijn (2012), Good SR (pooled analysis of 6 studies) Pooled estimates 77 74 N/A 2.94 0.31 9.61 Jarvik and Deyo (2002), Poor b SR (2 direct comparative studies) Study 1 88-94 57-64 0.85-0.86 2.1-6.9d 0.11-0.54d N/A Study 2 60 86 N/A N/A N/A N/A MRI Moranjkic (2011), Fair 1 study (direct comparison with CT) Study 1 91.6 66.7 0.875 N/A N/A N/A Wassenaar (2012), Fair SR (pooled analysis of 5 studies) Pooled estimates 75 77 –c 3.3 0.33 10.12 Jarvik and Deyo (2002), Poor b SR (2 direct comparative studies) Study 1 89-100 43-57 0.81-0.84 1.1-33d 0-0.93d N/A Study 2 64 87 N/A 1.1-33d 0-0.93d N/A LDH with nerve root compression MRI Wassenaar (2012), Fair SR (2 studies) Study 1 81 100 N/A N/A N/A N/A Study 2 92 52 N/A N/A N/A N/A Spinal stenosis CT Jarvik and Deyo SR (13 Range 70-100 80-96 N/A N/A N/A N/A
(2002), Poor b studies) Wassenaar (2012), Fair SR (2 studies) Study 1 96 68 N/A N/A N/A N/A Study 2 87 75 N/A N/A N/A N/A Jarvik and Deyo (2002), Poor b SR (5 studies) Ranges 81-97 72-100 N/A N/A N/A N/A Spondyloarthritis (sacroiliitis) CT Sidiropoulos (2008), Poor b SR (pooled analyses of 10 studies) Pooled estimates 49 100 N/A N/A N/A N/A MRI Sidiropoulos (2008), Poor b SR (2 pooled analyses of 8 & 5 studies) Pooled estimates 40/27 100/94 N/A N/A N/A N/A Jarvik and Deyo (2002), Poor b SR (1 study) Study 1 55 Not applicable N/A N/A N/A N/A Shankar (2009), Poor Case-control (1 study) Study 1 88 100 N/A N/A N/A N/A X-ray Sidiropoulos (2008), Poor b SR (pooled analyses of 18 studies) Pooled estimates 35 100 N/A N/A N/A N/A Jarvik and Deyo (2002), Poor b SR (1 study) Study 1 45 100 N/A N/A N/A N/A Shankar (2009), Poor Case-control (1 study) Study 1 0 100 N/A N/A N/A N/A Spinal MRI Jarvik and Deyo SR (5 Ranges 83-93 90-97 N/A 8.3-31 0.07-0.19 N/A
Table 034 Characteristics of included systematic reviews of diagnostic accuracy of imaging for low back pain Ref ID and Qualitya Literature search date and Study eligibility Number of studies, Number of patients and Setting Patient population index test Comparators Reference standard Outcome measures Meta-analysis van Rijn 2012 Good quality search to Dec 2009 prospective or retrospective cohort or case-control studies assessing diagnostic accuracy published full reports with sufficient data to construct a two-by-two table comparison with a reference standard 7 observational studies N=498 discs All identified studies were in the secondary care setting Adult patients with LBP or sciatica suspected to be caused by specific pathology: radicular syndrome spinal stenosis spinal tumours spinal infection/inflammation spondylolisthesis, spondylolysis, spinal fractures AS disc displacement osteoporotic fractures other degenerative disc diseases CT N/A surgical findings (6 studies) expert panel opinion (1 study) diagnostic work-up (0 studies) MRI (0 studies) sensitivity specificity positive LR negative LR Yes (6 out of the 7 studies) Wassenaar 2012 Fair quality search to Dec 2009 prospective or retrospective cohort or studies assessing diagnostic 8 observational studies N=467 patients All identified studies were in the Adult patients with LBP or sciatica suspected to be caused by lumbar spinal pathology: radicular syndrome spinal stenosis spinal tumours MRI N/A surgical findings (7 studies) expert panel consensus (1 study) diagnostic work-up (0 sensitivity specificity positive LR negative LR Yes (5 out of the 8 studies) control Intervention
accuracy published full reports with sufficient data to construct a two-by-two table comparison with a reference standard secondary care setting spinal infection/inflammation spondylolisthesis, spondylolysis, spinal fractures AS disc displacement osteoporotic fractures other degenerative disc diseases studies) Sidiropoulos 2008 (CPG) Poor quality search to Aug 2006 appropriate study population relevant outcomes with data on selected outcome measures excluded case reports, studies with TNF-α antagonists, animal studies, narrative Guideline included 467 papers covering diagnosis, treatment and monitoring Setting not specified Patients with ankylosing spondylitis and evident or suspected sacroiliitis X-ray MRI CT Not clear Not mentioned sensitivity specificity positive LR negative LR No
reviews, commentaries and duplications Jarvik 2002 Poor quality search from Jan 1966-Sep 2001 excluded animal studies, paediatric studies, case reports, review articles, editorials, and non-English articles 73 studies N=not reported Setting of included studies not reported but review focused on imaging modalities used in the primary care setting only Patients with LBP in the primary setting due to: herniated disc spinal stenosis spinal fracture spinal malignancy spinal infection AS CT MRI X-ray imaging (planar imaging, SPECT) MRI bone scintigraphy myelography expert panel consensus biopsy sensitivity specificity positive LR negative LR No Abbreviations: AS, ankylosing spondylitis; CPG, clinical practice guideline; CT, computed tomography; LBP, low back pain; LR, likelihood ratio; MRI, magnetic resonance imaging; SPECT, single-photon emission computerised tomography; TNF, tumour necrosis factor. a See Appendix 6 for quality assessment forms. Table 035 Characteristics of subsequent published primary studies of diagnostic accuracy of imaging for low back pain Ref ID and Qualitya Number of patients, Setting and Country Patient population Inclusions/Exclusions Intervention/ index test Comparators Reference standard Outcome measures Moranjkic 2011 Fair quality Prospective study of 70 patients (30 operated on due Patients with: radicular pain and evidence of nerve root irritation with a positive nerve root tension sign or a corresponding neurologic deficit MRI CT N/A surgical findings sensitivity specificity
Mortimer 2013 C/E analysis based on a RCT Australia Healthcare Primary care Patients with acute LBP Active implementation of the AAMPGG guidelines Standard implementation of AAMPGG guidelines Cost per X-ray avoided Kim 2011 C/E analysis based on prospective cohort study Canada Healthcare Hospital outpatients Outpatients with back pain referred to a surgical practice Triage program based on 2001 Ontario guidelines (± ± MRI) Usual care (MRI, CT and/or X-ray) ICER Jensen 2010 Cost analysis based on a comparison of two cohorts Denmark Healthcare Public outpatient clinic Adults with LBP or leg pain rated at least 3 on an 11-point numeric rating scale of 2-12 months duration Routine MRI Needs-based MRI Incremental cost Incremental duration of treatment Gilbert 2004 C/E analysis based on a RCT UK Healthcare Specialist care Symptomatic lumbar spine disorder with clinical uncertainty about need for imaging Early MRI/CT Delayed MRI/CT (no imaging unless clinical indication subsequently developed) ICER Jarvik 2003 Cost analysis based on a US Healthcare Primary care LBP ± radiating leg pain Rapid MRI X-ray Incremental cost Incremental
Table A-6.8 Randomised controlled trial Gilbert 2004 Quality criteria Questions considered Yes, no, not reported (NR) or not applicable (NA) Level A. Was assignment of subjects to treatment group randomised? Was the use of randomisation reported? Yes I Was the method of randomisation reported? Yes III Was the method of randomisation appropriate? Yes I-III B. Was allocation to treatment groups concealed from those responsible for recruiting subjects? Was a method of allocation concealment reported? Yes III Was the method of allocation concealment adequate? Yes III C. Was the study double-blinded? Were subjects and investigators blinded to treatment arm? No II-IV D. Were patient characteristics and demographics similar between treatment arms at baseline? Were baseline patient characteristics and demographics reported? Yes III Were the characteristics similar between treatment arms? Yes III-IV E. Were all randomised participants included in the analysis? Was loss to follow-up reported? Yes II Was loss to follow-up appropriately accounted for in the analysis? Yes III-IV F. Was outcome assessment likely to be subject to bias? Were all relevant outcomes measured in a standard, valid, and reliable way? Yes III-IV Was outcome assessment blinded to treatment allocation? No III If outcome assessment was not blinded, were outcomes objective and unlikely to be influenced by blinding of assessment? NA III G. Were the statistical methods appropriate? Were the methods used for comparing results between treatment arms appropriate? Yes III If the study was carried out at more than one site, are the results comparable for all sites? NR IV H. If appropriate, were any subgroup analyses carried out? Were subgroup analyses reported? Yes III-IV Were subgroup analyses appropriate? Yes III-IV
Table A-6.9 Randomised controlled trial Dey 2004 Quality criteria Questions considered Yes, no, not reported (NR) or not applicable (NA) Level A. Was assignment of subjects to treatment group randomised? Was the use of randomisation reported? Yes I Was the method of randomisation reported? Yes III Was the method of randomisation appropriate? Yes I-III B. Was allocation to treatment groups concealed from those responsible for recruiting subjects? Was a method of allocation concealment reported? Yes III Was the method of allocation concealment adequate? Yes III C. Was the study double-blinded? Were subjects and investigators blinded to treatment arm? No II-IV D. Were patient characteristics and demographics similar between treatment arms at baseline? Were baseline patient characteristics and demographics reported? Yes III Were the characteristics similar between treatment arms? Yes III-IV E. Were all randomised participants included in the analysis? Was loss to follow-up reported? Yes II Was loss to follow-up appropriately accounted for in the analysis? Yes III-IV F. Was outcome assessment likely to be subject to bias? Were all relevant outcomes measured in a standard, valid, and reliable way? Yes III-IV Was outcome assessment blinded to treatment allocation? No III If outcome assessment was not blinded, were outcomes objective and unlikely to be influenced by blinding of assessment? No III G. Were the statistical methods appropriate? Were the methods used for comparing results between treatment arms appropriate? Yes III If the study was carried out at more than one site, are the results comparable for all sites? NR IV H. If appropriate, were any subgroup analyses carried out? Were subgroup analyses reported? No III-IV Were subgroup analyses appropriate? NR III-IV