There is an increasing awareness of the risks and dangers of exposure to radiation associated with repeated radiographic assessment of spinal curvature and spinal movements. As such, attempts are continuously being made to develop skinsurface devices for use in examining the progression and response to treatment of various spinal disorders. However, the reliability and validity of measurements recorded with such devices must be established before they can be recommended for use in the research or clinical environment. The aim of this study was to examine the reliability of measurements using a newly developed skin-surface device, the Spinal Mouse. Twenty healthy volunteers (mean age 41±12 years, nine males, 11 females) took part. On 2 separate days, spinal curvature was measured with the Spinal Mouse during standing, full flexion, and full extension (each three times by each of two examiners). Paired t-tests, intraclass correlation coefficients (ICC), and standard errors of measurement (SEM) with 95% confidence intervals were used to characterise between-day and interexaminer reliability for: standing sacral angle, lumbar lordosis, thoracic kyphosis, and ranges of motion (flexion, extension) of the thoracic spine, lumbar spine, hips, and trunk. The between-day reliability for segmental ranges of flexion was also determined for each motion segment from T1-2 to L5-S1. The majority of parameters measured for the 'global regions' (thoracic, lumbar, or hips) showed good between-day reliability. Depending on the parameter of interest, between-day ICCs ranged from 0.67 to 0.92 for examiner 1 (average 0.82) and 0.57 to 0.95 for examiner 2 (average 0.83); for 70% of the parameters measured, the ICCs were greater than 0.8 and generally highest for the lumbar spine and whole trunk measures. For lumbar spine range of flexion, the SEM was approximately 3°. The ICCs were also good for the interexaminer comparisons, ranging from 0.62 to 0.93 on day 1 (average 0.81) and 0.70 to 0.94 on day 2 (average 0.86), although small systematic differences were sometimes observed in their mean values. The latter were still evident even if both examiners used the same skin markings. For segmental ranges of flexion, the ICCs varied between vertebral levels but overall were lower than for the global measures (average for all levels in all analyses, ICC 0.6). For each examiner, the average between-day SEM over all vertebral levels was approximately 2°. For 'global' regions of the spine, the Spinal Mouse delivered consistently reliable values for standing curvatures and ranges of motion which compared well with those reported in the literature. This suggests that the device can be reliably implemented for in vivo studies of the ORIGINAL ARTICLE Eur Spine J (2004) 13 : 122-136 DOI 10.1007 Anne F. Mannion Katrin Knecht Gordana Balaban Jiri Dvorak Dieter Grob A new skin-surface device for measuring the curvature and global and segmental ranges of motion of the spine: reliability of measurements and comparison with data reviewed from the ...

The present study examined the psychometric characteristics of a "core-set" of six individual questions (on pain, function, symptom-specific well-being, work disability, social disability and satisfaction) for use in low back pain (LBP) outcome assessment. A questionnaire booklet was administered to 277 German-speaking LBP patients with a range of common diagnoses, before and 6 months after surgical (N=187) or conservative (N=90) treatment. The core-set items were embedded in the booklet alongside validated 'reference' questionnaires: Likert scales for back/leg pain; Roland and Morris disability scale; WHO Quality of Life scale; Psychological General Well-Being Index. A further 45 patients with chronic LBP completed the booklet twice in 1-2 weeks. The minimal reliability (similar to Cronbach's alpha) for each core item was 0.42-0.78, increasing to 0.84 for a composite index score comprising all items plus an additional question on general well-being ('quality of life'). Floor or ceiling effects of 20-50% were observed for some items before surgery (function, symptom-specific well-being) and some items after it (disability, function). The intraclass correlation coefficient (ICC) ("test-retest reliability") was moderate to excellent (ICC, 0.67-0.95) for the individual core items and excellent (ICC, 0.91) for the composite index score. With the exception of "symptom-specific well-being", the correlations between each core item and its corresponding reference questionnaire ("validity") were between 0.61 and 0.79. Both the composite index and the individual items differentiated (P<0.001) between the severity of the back problem in surgical and conservative patients (validity). The composite index score had an effect size (sensitivity to change) of 0.95, which was larger than most of the reference questionnaires (0.47-1.01); for individual core items, the effect sizes were 0.52-0.87. The core items provide a simple, practical, reliable, valid and sensitive assessment of outcome in LBP patients. We recommend the widespread and consistent use of the core-set items and their composite score index to promote standardisation of outcome measurements in clinical trials, multicentre studies, routine quality management and surgical registry systems.

Patient-orientated assessment methods are of paramount importance in the evaluation of treatment outcome. The Oswestry Disability Index (ODI) is one of the condition-specific questionnaires recommended for use with back pain patients. To date, no German version has been published in the peerreviewed literature. A cross-cultural adaptation of the ODI for the German language was carried out, according to established guidelines. One hundred patients with chronic low-back pain (35 conservative, 65 surgical) completed a questionnaire booklet containing the newly translated ODI, along with a 0-10 pain visual analogue scale (VAS), the Roland Morris Disability Questionnaire, and Likert scales for disability, medication intake and pain frequency [to assess ODI's construct (convergent) validity]. Thirty-nine of these patients completed a second questionnaire within 2 weeks (to assess test-retest reliability). The intraclass correlation coefficient for the test-retest reliability of the questionnaire was 0.96. In test-retest, 74% of the individual questions were answered identically, and 21% just one grade higher or lower. The standard error of measurement (SEM) was 3.4, giving a ''minimum detectable change'' (MDC 95% ) for the ODI of approximately 9 points, i.e. the minimum change in an individual's score required to be considered ''real change'' (with 95% confidence) over and above measurement error. The ODI scores correlated with VAS pain intensity (r=0.78, P<0.001) and Roland Morris scores (r=0.80, P<0.001). The mean baseline ODI scores differed significantly between the surgical and conservative patients (P<0.001), and between the different categories of the Likert scales for disability, medication use and pain frequency (in each case P<0.001). Our German version of the Oswestry questionnaire is reliable and valid, and shows psychometric characteristics as good as, if not better than, the original English version. It should represent a valuable tool for use in future patient-orientated outcome studies in German-speaking lands.

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We reviewed 161 patients, from four centres in Switzerland, who had undergone posterior fusion of the upper cervical spine with transarticular screw fixation of the atlanto-axial joints. They were followed up for a mean 24.6 months. The vertebral artery and the medulla escaped injury and only 5.9% of the complications were directly related to the screws. The rate of pseudarthrosis was 0.6%.

Degenerative changes of the cervical spine are commonly accompanied by a reduction or loss of the segmental or global lordosis, and are often considered to be a cause of neck pain. Nonetheless, such changes may also remain clinically silent. The aim of this study was to examine the correlation between the presence of neck pain and alterations of the normal cervical lordosis in people aged over 45 years. One hundred and seven volunteers, who were otherwise undergoing treatment for lower extremity problems in our hospital, took part. Sagittal radiographs of the cervical spine were taken and a questionnaire was completed, enquiring about neck pain and disability in the last 12 months. Based on the latter, subjects were divided into a group with neck pain (N = 54) and a group without neck pain (N = 53). The global curvature of the cervical spine (C2-C7) and each segmental angle were measured from the radiographs, using the posterior tangent method, and examined in relation to neck complaints. No significant difference between the two groups could be found in relation to the global curvature, the segmental angles, or the incidence of straight-spine or kyphotic deformity (P > 0.05). Twenty-three per cent of the people with neck pain and 17% of those without neck pain showed a segmental kyphosis deformity of more than 4°in at least one segment-most frequently at C4/5, closely followed by C5/6 and C3/4. The average segmental angle at the kyphotic level was 6.5°in the pain group and 6.3°i n the group without pain, with a range of 5-10°in each group. In the group with neck pain, there was no association between any of the clinical characteristics (duration, frequency, intensity of pain; radiating pain; sensory/motor disturbances; disability; healthcare utilisation) and either global cervical curvature or segmental angles. The presence of such structural abnormalities in the patient with neck pain must be considered coincidental, i.e. not necessarily indicative of the cause of pain. This should be given due consideration in the differential diagnosis of patients with neck pain.

The Core Outcome Measures Index (COMI) is a short, multidimensional outcome instrument, with excellent psychometric properties, that has been recommended for use in monitoring the outcome of spinal surgery from the patient's perspective. This study examined the feasibility of implementation of COMI and its performance in clinical practice within a large Spine Centre. Beginning in March 2004, all patients undergoing spine surgery in our Spine Centre (1,000-1,200 patients/year) were asked to complete the COMI before and 3, 12 and 24 months after surgery. The COMI has one question each on back (neck) pain intensity, leg/buttock (arm/shoulder) pain intensity, function, symptom-specific well being, general quality of life, work disability and social disability, scored as a 0-10 index. At follow-up, patients also rated the global effectiveness of surgery, and their satisfaction with their treatment in the hospital, on a five-point Likert scale. After some fine-tuning of the method of administration, completion rates for the pre-op COMI improved from 78% in the first year of operation to 92% in subsequent years (non-response was mainly due to emergencies or language or age issues). Effective completion rates at 3, 12 and 24-month follow-up were 94, 92 and 88%, respectively. The 12-month global outcomes (from N = 3,056 patients) were operation helped a lot, 1,417 (46.4%); helped, 860 (28.1%); helped only little, 454 (14.9%); did not help, 272 (8.9%); made things worse, 53 (1.7%). The mean reductions in COMI score for each of these categories were 5.4 (SD2.5); 3.1 (SD2.2); 1.3 (SD1.7); 0.5 (SD2.2) and -0.7 (SD2.2), respectively, yielding respective standardised response mean values ("effect sizes") for each outcome category of 2.2, 1.4, 0.8, 0.2 and 0.3, respectively. The questionnaire was feasible to implement on a prospective basis in routine practice, and was as responsive as many longer spine outcome questionnaires. The shortness of the COMI and its multidimensional nature make it an attractive option to comprehensively assess all patients within a given Spine Centre and hence avoid selection bias in reporting outcomes.

The Core Outcome Measures Index (COMI) is a reliable and valid instrument for assessing multidimensional outcome in spine surgery. The minimal clinically important score-difference (MCID) for improvement (MCID imp ) was determined in one of the original research studies validating the instrument, but has never been confirmed in routine clinical practice. Further, the MCID for deterioration (MCID det ) has never been investigated; indeed, this needs very large sample sizes to obtain sufficient cases with worsening. This study examined the MCIDs of the COMI in routine clinical practice. All patients undergoing surgery in our Spine Center since February 2004 were asked to complete the COMI before and 12 months after surgery. The COMI has one question each on back (neck) pain intensity, leg/buttock (arm/shoulder) pain intensity, function, symptom-specific well-being, general quality of life, work disability, and social disability, scored as a 0-10 index. At follow-up, patients also rated the global effectiveness of surgery, on a 5-point Likert scale. This was used as the external criterion (''anchor'') in receiver operating characteristics (ROC) analyses to derive cut-off scores for individual improvement and deterioration. Twelve-month follow-up questionnaires were returned by 3,056 (92%) patients. The group mean COMI score change for patients declaring that the ''operation helped'' was a reduction of 3.1 points; the corresponding value for those whom it ''did not help'' was a reduction of 0.5 points. The group MCID imp was hence 2.6 points reduction; the corresponding group MCID det was 1.2 points increase (0.5 minus -0.7). The area under the ROC curve was 0.88 for MCID imp and 0.89 for MCID det (both P \ 0.0001), indicating that the COMI had good discriminative ability. The cut-offs for individual improvement and deterioration, respectively, were C2.2 points decrease (sensitivity 81%, specificity 83%) and C0.3 points increase (sensitivity 83%, specificity 88%). The MCID imp score of 2.2 points was similar to that reported in the original study (2-3 points, depending on external criterion used). The MCID det suggested that the COMI is less responsive to deterioration than to improvement, a phenomenon also reported for other spine outcome instruments. This needs further investigation in even larger patient groups. The MCIDs provide essential information for both the planning (sample size) and interpretation of the results (clinical relevance) of future clinical studies using the COMI.