Core Outcome Measures Index Research Articles

Minimum clinically important difference of the health-related quality of life scales in adult spinal deformity calculated by latent class analysis: is it appropriate to use the same values for surgical and nonsurgical patients?

BACKGROUND CONTEXTHealth-related quality of life (HRQOL) parameters have been shown to be reliable and valid in patients with adult spinal deformity (ASD). Minimum clinically important difference (MCID) has become increasingly important to clinicians in evaluating patients with a threshold of improvement that is clinically relevant. PURPOSETo calculate MCID and minimum detectable change (MDC) values of total scores of the Core Outcome Measures Index (COMI), Oswestry Disability Index (ODI), Physical Component Summary (PCS), Mental Component Summary (MCS) of the Short Form 36 (SF-36), and Scoliosis Research Society 22R (SRS-22R) in surgically and nonsurgically treated ASD patients who have completed an anchor question at pretreatment and 1-year follow-up. STUDY DESIGN/SETTINGProspective cohort. PATIENT SAMPLESurgical and nonsurgical patients from a multicenter ASD database. OUTCOME MEASURESSelf-reported HRQOL measures (COMI, ODI, SF-36, SRS-22R, and anchor question). METHODSA total of 185 surgical and 86 nonsurgical patients from a multicenter ASD database who completed pretreatment and 1-year follow-up HRQOL scales and the anchor question at the first year follow-up were included. The anchor question was used to determine MCID for each HRQOL measure. MCIDs were calculated by an anchor-based method using latent class analysis (LCA) and MDCs by a distribution-based method. RESULTSAll differences between means of baseline and first year postoperative total score measures for all scales demonstrated statistically significant improvements in the overall population as well as the surgically treated patients but not in the nonsurgical group. The calculated MDC and MCID values of HRQOL parameters in the entire study population were 1.34 and 2.62 for COMI, 10.65 and 14.31 for ODI, 6.09 and 7.33 for SF-36 PCS, 6.14 and 4.37 for SF-36 MCS, and 0.42 and 0.71 for SRS-22R. The calculated MCID values for surgical and non-surgical treatment groups were 2.76 versus 1.20 for COMI, 14.96 versus 2.45 for ODI, 7.83 versus 2.15 for SF-36 PCS, 5.14 versus 2.03 for SF-36 MCS, and 0.94 versus 0.11 for SRS-22R; the MDC values for surgical and nonsurgical treatment groups were 1.22 versus 1.51 for COMI, 10.27 versus 9.45 for ODI, 5.16 versus 6.77 for SF-36 PCS, 6.05 versus 5.67 for SF-36 MCS, and 0.38 versus 0.43 for SRS-22R. CONCLUSIONSThis study has demonstrated that MCID calculations for the HRQOL scales in ASD using LCA yield values comparable to other studies that had used different methodologies. The most important finding was the significantly different MCIDs for COMI, ODI, SF-36 PCS and SRS-22 in the surgically and nonsurgically treated cohorts. This finding suggests that a universal MCID value, inherent to a specific HRQOL for an entire cohort of ASD may not exist. Use of different MCIDs for surgical and nonsurgical patients may be warranted.

Clinical experiences with a PEEK-based dynamic instrumentation device in lumbar spinal surgery: 2\xa0years and no more

BackgroundDynamic spine implants were developed to prevent adjacent segment degeneration (ASD) and adjacent segment disease (ASDi). Purpose of this study was to investigate the clinical and radiological outcomes of “topping off” devices following lumbar spinal fusion procedure using a PEEK-based dynamic rod system. Moreover, this study focused on the hypothesis that “topping off” devices can prevent ASD.MethodsThis prospective nonrandomized study included patients with indication for single-level lumbar fusion and radiological signs of ASD without instability. The exclusion criteria were previous lumbar spine surgery and no sign of disc degeneration in the adjacent segment according to magnetic resonance imaging. All patients were treated with single-level lumbar interbody fusion and dynamic stabilization of the cranial adjacent segment. Patients underwent a clinical examination and radiographs preoperatively and at 1 and 2 years after surgery. Analyses were performed on clinical data collected with the German Spine Registry using the core outcome measure index (COMI) and visual analogue scale (VAS) scores for back and leg pain.ResultsA total of 22 patients (6 male and 16 female) with an average age of 57.6 years were included in the study; 20 patients completed the follow-up (FU). The average COMI score was 9.0 preoperatively, 4.2 at the 1-year FU, and 4.7 at the 2-year FU. The average preoperative VAS scores for back and leg pain were 7.7 and 7.1, respectively. At the 1-year FU, the scores were 4.25 for back pain and 2.2 for leg pain, and at the 2-year FU, the scores were 4.7 for back pain and 2.3 for leg pain. At FU, failure of the dynamic topping off implant material was verified in four cases, and ASD of the segment cranial to the topping off was confirmed in three cases.ConclusionsThese results demonstrate significant improvements in clinical outcomes and pain reduction after lumbar spinal fusion with topping off at 2 years after surgery. However, the implant failed due to the high rate of implant failure and the development of ASD in the segment cranial to the dynamic stabilized segment.

Can We Assess the Success of Surgery for Degenerative Spinal Diseases Using Patients' Recall of Their Preoperative Status?

Patients' recall of their preoperative status is seldom used to assess surgical outcomes because of concerns about inaccuracy and bias. The present study aimed to measure the significance of this recall bias and its repercussion on patients' recollection of their preoperative status. Patients submitted to surgery due to degenerative spine diseases over a 1-year period (n= 198) were included in this study. Each patient completed the EuroQol Five-Dimensional Questionnaire (including a visual analog scale), Core Outcome Measures Index (COMI) for neck (including neck pain and shoulder/arm pain numeric rating scale [NRS]), COMI back (including back pain and buttock/leg pain NRS), Neck Disability Index, and Oswestry Disability Index preoperatively. At 1 year after surgery, the patients were asked to complete 2 sets of the same questionnaires, one set regarding their postoperative status and the other set regarding their recall of their preoperative status. There was poor to moderate agreement between recalled and collected preoperative scores for all patient-reported outcome measures. Patients' recollection of their preoperative status was accurate for patients who underwent cervical spine surgery, but not for those who underwent lumbar spine surgery. Patients satisfied with the outcome after lumbar spine surgery recalled significantly worse scores compared with the actual preoperative scores. Using patients' recall of their preoperative status may lead to overestimation of the effectiveness of surgery, particularly for lumbar spine surgery. The self-assessed effectiveness of surgery interferes with the recollection of baseline status.

Relative pelvic version: an individualized pelvic incidence-based proportional parameter that quantifies pelvic version more precisely than pelvic tilt

Background ContextPelvic tilt (PT) is used as an indicator of pelvic version with increased values indicating retroversion and disability. The concept of using PT solely as an absolute numerical value can be misleading, especially for the patients with pelvic incidence (PI) values near the upper and lower normal limits. Relative pelvic version (RPV) is a PI-based individualized measure of the pelvic version. Relative pelvic version indicates the individualized spatial orientation of the pelvis relative to the ideal sacral slope as defined by the magnitude of PI. PurposeThe aim of this study was to compare RPV and PT for their ability to predict mechanical complications and their correlations with health-related quality of Life (HRQoL) scores. Study DesignA retrospective analysis of a prospectively collected data of adult spinal deformity patients was carried out. Mechanical complications (proximal junctional kyphosis or proximal junctional failure, distal junctional kyphosis or distal junctional failure, rod breakage, and implant-related complications) and HRQoL scores (Oswestry Disability Index [ODI], Core Outcome Measures Index [COMI], Short Form-36 Physical Component Summary [SF-36 PCS], and Scoliosis Research Society 22 Spinal Deformity Questionnaire [SRS-22]) were used as outcome measures. MethodsInclusion criteria were ≥4 levels fusion, and ≥2-year follow-up. Correlations between PT, RPV, PI, and HRQoL were analyzed using Pearson correlation coefficient. Pelvic incidence values and mechanical complication rates in RPV subgroups for each PT category were compared using one-way analysis of variance, Student t test, and chi-squared tests. Predictive models for mechanical complications with RPV and PT were analyzed using binomial logistic regressions. ResultsA total of 222 patients (168 women, 54 men) met the inclusion criteria. Mean age was 52.2±19.3 (18–84) years. Mean follow-up was 28.8±8.2 (24–62) months. There was a significant correlation between PT and PI (r=0.613, p<.001), threatening the use of PT to quantify pelvic version for different PI values. Relative pelvic version was not correlated with PI (r=−0.108, p>.05), being able to quantify pelvic version for all PI values. Compared with PT, RPV had stronger partial correlations with ODI, COMI, SF-36 PCS, and SRS-22 scores (p<.05). Discrimination performance assessed by area under the curve, percentage accuracy in classification, true positive rate, true negative rate, and positive and negative predictive values was better for the model with RPV than for PT. For average PI sizes, the agreement between RPV and PT were moderate (0.609, p<.001), whereas the agreement in small and large PI sizes were poor (0.189, p>.05; −0.098, p>.496, respectively). When analyzed by RPV, each PT “0,” “+,” and “++” category was further divided into two or three distinct subgroups of patients having different PI values (p=.000, p=.000, and p=.029, respectively). Relative pelvic version subgroups within the same PT category displayed different mechanical complication rates (p=.000, p=.020, and p=.019, respectively). ConclusionsPelvic tilt may be insufficient or misleading in quantifying normoversion for the whole spectrum of PI values when used as an absolute numeric value in conjunction with previously reported population-based average thresholds of 20 and 30 degrees. Relative pelvic version offers an individualized quantification of ante-, normo-, and retroversion for all PI sizes. Schwab PT groups were found to constitute inhomogeneous subgroup of patients with different mean PI values and mechanical complication rates. Compared with PT, RPV showed a greater association with both mechanical complications and HRQoL.

Development of the Japanese Core Outcome Measures Index (COMI): cross-cultural adaptation and psychometric validation

BackgroundThe patient-rated Core Outcome Measures Index (COMI) assesses the multidimensional impact of back problems on the sufferer. The brevity and comprehensibility of the tool make it practical for use in clinical and research settings. Although the COMI has been cross-culturally adapted in various languages worldwide, there is currently no Japanese version. The aim of this study was to develop a Japanese version of the COMI by: (1) performing a cross-cultural adaptation of the English version and (2) evaluating the psychometric properties of the Japanese version of the COMI in Japanese volunteers with chronic back problems.MethodsThe English version of the COMI was cross-culturally adapted for the Japanese language using established guidelines. The pre-final version was pilot-tested in five Japanese-speaking patients with low back pain (LBP) and a history of spine surgery. The psychometric properties of the Japanese COMI were tested in a group of 1052 individuals with chronic LBP (LBP ≥3 months), aged 20–69 years, who were recruited through a web-based survey. The psychometric properties that were evaluated included convergent and known-group validity, using the following reference questionnaires: EuroQol 5 Dimension, Roland Morris Disability Questionnaire, Short Form 8™ Health Survey, and the Keele STarT Back Screening Tool.ResultsThe pre-final version of the cross-culturally adapted Japanese COMI was completed without any major problems of understanding or acceptability. For the evaluation of its psychometric properties, tests for convergent validity showed moderate correlations between COMI items and the respective reference questionnaires for symptom-specific well-being [− 0.33–−0.48] and disability domains [0.48] and strong correlations (> 0.5) for the other domains and the COMI summary score. The analysis of known-group validity showed a linear trend for the COMI score in relation to prognostic risk (P < 0.001).ConclusionsThe Japanese COMI retained conceptual equivalence to the original using comprehensible and acceptable Japanese expressions. We developed a Japanese version of the COMI that displayed qualities that support its convergent and known-group validity. The availability of a Japanese version of the COMI should allow for improved documentation of the care provided to patients with back problems.

EUROSPINE 2017 FULL PAPER AWARD: Time to remove our rose-tinted spectacles: a candid appraisal of the relative success of surgery in over 4500 patients with degenerative disorders of the lumbar spine, hip or knee

Studies comparing the outcome of spine surgery with that of large-joint replacement report equivocal findings. The patient-reported outcome measures (PROMs) used in such studies are typically generic and may not be sufficiently sensitive to the successes/failures of treatment. This study compared different indices of "success" in patients undergoing surgery for degenerative disorders of the lumbar spine, hip, or knee, using a validated, multidimensional, and joint-specific PROM. Preoperatively and 12months postoperatively, 4594 patients (3937 lumbar spine, 368 hip, 269 knee) undergoing first-time surgery completed a PROM that included the Core Outcome Measures Index (COMI) for the affected joint. The latter comprises a set of single items on pain, function, symptom-specific well-being, quality of life, and disability-all in relation to the specified joint problem. Other single-item ratings of treatment success were made 12 months postoperatively. In multiple regression analyses, controlling for confounders, the mean improvement in COMI at 12months was greatest for the hip patients and lowest for those with degenerative spinal deformity (=the statistical reference group) (p<0.05). Compared with spinal deformity, the odds of achieving "success" were: higher for hip (OR 4.6; 95% CI 2.5-8.5) and knee (OR 4.0; 95% CI 2.1-7.7) (no difference between spine subgroups) for "satisfaction with care"; higher for hip (OR 16.9; 95% CI 7.3-39.6), knee (OR 6.3; 95% CI 3.4-11.6), degenerative spondylolisthesis (OR 1.6; 95% CI 1.2-2.2), and herniated disc (OR 1.7; 95% CI 1.2-2.4) for "global treatment outcome"; and higher for hip (OR 13.8; 95% CI 8.8-21.6), knee (OR 5.3; 95% CI 3.6-7.8), degenerative spondylolisthesis (OR 1.6; 95% CI 1.3-2.1), and herniated disc (1.5; 95% CI 1.1-2.0) for "patient-acceptable symptom state". Patient-rated complications were the greatest in degenerative spinal deformity (29%) and the lowest in hip (18%). The current study is the largest of its kind and the first to use a common, but joint-specific instrument to report patient-reported outcomes after surgery for degenerative disorders of the spine, hip, or knee. The findings provide a sobering account of the significantly poorer outcomes after spine surgery compared with large-joint replacement. Further work is required to hone the indications and patient selection criteria for spine surgery. The data should be used to lobby research funding-bodies, governmental agencies, industry, and charitable foundations to invest more in spine research/registries, in the hope of ultimately improving spine outcomes. These slides can be retrieved under Electronic Supplementary Material.

Can bracing help adults with chronic back pain and scoliosis? Short-term results from a pilot study.

Adult scoliosis is sometimes associated with back pain. Recently, the Peak™ Scoliosis Brace was designed to alleviate pain in adult patients with scoliosis. To test the efficacy of the Peak Scoliosis Brace in reducing pain in adult scoliosis patients. Prospective experimental cohort study. A total of 20 adult females with back pain secondary to idiopathic scoliosis were included. Patients were evaluated at baseline immediately before starting bracing and after 1 month. The brace had to be worn for at least 2 h per day. The outcome measures used were Graphical Rating Scale, Roland-Morris Questionnaire, Core Outcome Measurement Index, and Oswestry Disability Index. Worst pain, back pain, and leg pain significantly improved from 7.15 to 5.85, from 6.55 to 5.25, and from 5.65 to 3.55, respectively ( p < 0.05). A total of 75% of patients reported improved worst and leg pain, 65% improved back pain, 30% of patients achieved the minimal clinically significant difference of 2 points for worst pain, 60% for leg pain, and 25% for back pain. Roland-Morris Questionnaire and Core Outcome Measurement Index improved ( p < 0.05) and no differences were observed for Oswestry Disability Index. The Peak Scoliosis Brace led to some improvement of pain at 1 month in a group of adult women with scoliosis and chronic low back pain. The quality of life did not change significantly. Clinical relevance According to our data, the Peak Brace is helpful to quickly improve pain in patients with chronic low back pain secondary to scoliosis. To achieve this goal, it should be applied for at least 2 h per day.

The influence of surface EMG-triggered multichannel electrical stimulation on sensomotoric recovery in patients with lumbar disc herniation: study protocol for a randomized controlled trial (RECO)

BackgroundIntervertebral disc degeneration is one of the most common reasons for chronic low back pain and sensomotoric deficits, often treated by lumbar sequestrectomy. Nevertheless, the prognostic factors relevant for time and quality of recovery, of the surgical procedure, relative to conservative treatment, remain controversial and require further investigation. Surface electrical stimulation (SES) may be an influential intervention, already showing positive impact on motor and sensory recovery in different patient groups. Since mechanisms of SES still remain unclear, further inquiry is needed.Methods/DesignThis is a prospective, monocentric, randomized, controlled clinical trial. A total of 80 adult patients suffering from a lumbar disc herniation (LDH; 40 treated surgically, 40 conservatively) are allocated in a ratio of 1:1. Patients in the treatment group will receive surface electromyography (EMG)-triggered electrical stimulation for eight weeks, whereas patients in the control group will not obtain any additional treatment. The primary outcome parameter is defined as the cold detection threshold (CDT), determined by quantitative sensory testing (QST), 24 months after intervention. Secondary outcome parameters include the inquiry of sensory nerve function by two-point discrimination and QST, the assessment of motor nerve function by manual muscle testing, and validated scales and scores. These include: the Oswestry Disability Index (ODI) and the Core Outcome Measures Index (COMI) assessing the domains pain, back-specific function, work disability, and patient satisfaction; the EQ-5D investigating the patient’s generic health status; the painDETECT questionnaire (PD-Q) to identify neuropathic pain components; and the Beck Depression Inventory (BDI) to assess severity of depression. Moreover, neurological status, pain medication usage, and blood samples (CRP, TNFα, IL-1β, IL-6) will be evaluated. Study data generation (study site) and data storage, processing, and statistical analysis are clearly separated.DiscussionThe results of the RECO study will detect the effect of EMG-triggered multichannel SES on the improvement of mechanical and thermal sensitivity and the effect on motor recovery and pain, associated with clinical and laboratory parameters. Furthermore, data comparing surgical and conservative treatment can be collected. This will hopefully allow treatment recommendations for patients with LDH accompanied by a sensomotoric deficit.Trial registrationISRCTN, ISRCTN12741173. Registered on 15 January 2017.

How does patient-rated outcome change over time following the surgical treatment of degenerative disorders of the thoracolumbar spine?

Patient-rated measures are considered the gold standard for assessing the outcome of spine surgery, but there is no consensus on the appropriate timing of follow-up. Journals often demand a minimum 2-year follow-up, but the indiscriminate application of this principle may not be warranted. We examined the course of change in patient outcomes up to 5years after surgery for degenerative spinal disorders. The data were evaluated from 4287 consecutive patients (2287 women, 2000 men; aged 62±15years) with degenerative disorders of the thoracolumbar spine, undergoing first-time surgery at the given level between 01/01/2005 and 31/12/2011. The Core Outcome Measures Index (COMI; scored 0-10) was completed by 4012 (94%) patients preoperatively, 4008 (93%) at 3-month follow-up, 3897 (91%) at 1-year follow-up, 3736 (87%) at 2-year follow-up, and 3387 (79%) at 5-year follow-up. 2959 (69%) completed the COMI at all five time-points. The individual COMI change scores from preoperatively to the various follow-up time-points showed significant correlations ranging from r=0.50 (for change scores at the earliest vs the latest follow-up) to r=0.75 (for change scores after 12- vs 24-month follow-up). Concordance with respect to whether the minimum clinically important change score was achieved at consecutive time-points was also good (70-82%). COMI decreased significantly (p<0.05) from preop to 3months (by 3.6±2.8 points) and from 3 to 12months (by 0.3±2.4 points), then levelled off up to 5years (0.04-0.05 point change; p>0.05). The course of change up to 12months differed slightly (p<0.05) depending on pathology/whether fusion was carried out. For patients undergoing simple decompression, 3-month follow-up was sufficient; those undergoing fusion continued to show further slight but significant change up to 12months. Stable group mean COMI scores were observed for all patients from 12months postoperatively onwards. The early postoperative results appeared to herald the longer term outcome. As such, a 'wait and see policy' in patients with a poor initial outcome at 3months is not advocated. The insistence on a 2-year follow-up could result in a failure to intervene early to achieve better long-term outcomes.

Reliability and validity of the cross-culturally adapted Turkish version of the Core Outcome Measures Index for low back pain.

To produce a cross-culturally adapted and validated Turkish version of The Core Outcome Measure Index (COMI) Back questionnaire. Ninety-six Turkish-speaking patients with non-specific low back pain (LBP) were recruited from orthopedic and physical therapy outpatient clinics in a public hospital. They completed a booklet of questionnaires containing Turkish version of COMI, adjectival pain scale, Roland Morris disability questionnaire, European 5 Dimension Questionnaire and brief version of World Health Organization Quality of Life Questionnaire. Within following 7-14days, 67 patients, reported no or minimal changes in their back pain status, completed the Turkish COMI again to assess reproducibility. Data quality was good with very few missing answers. COMI summary index score displayed 3% floor effects and no ceiling effects. The correlations between the COMI summary index score and each of the full instrument whole scores were found to be excellent to very good (ρ=- 0.81 to 0.74). Reliability expressed as intraclass correlation coefficient (ICC) was 0.95 (95% CI 0.91-0.97). Standard error of measurement (SEMagreement) was acceptable at 0.41 and the minimum detectable change (MDC95%) was 1.14. Turkish version of the COMI has acceptable psychometric properties. It is a valid and reliable instrument and cross-culturally adapted, in accordance with established guidelines, for the use by Turkish-speaking patients. It can be recommended for use in evaluation of patients with chronic LBP in daily practice, in international multicenter studies and in spine registry systems.

168 - The Core Outcome Measures Index (COMI) is a Responsive Measure of Patient-Rated Outcome After Surgery for Cervical Myelopathy

168 - The Core Outcome Measures Index (COMI) is a Responsive Measure of Patient-Rated Outcome After Surgery for Cervical Myelopathy

Dural sac cross-sectional area and morphological grade show significant associations with patient-rated outcome of surgery for lumbar central spinal stenosis.

Lumbar central spinal stenosis (LSS) is one of the most common reasons for spine surgery in the elderly patient. Magnetic resonance imaging (MRI) represents the gold standard for the assessment of LSS and can be used to obtain quantitative measures of the dural sac cross-sectional area (DCSA) or qualitative measures (morphological grades A-D) of the rootlet/cerebrospinal fluid ratio. This study investigated the intercorrelation between these two MRI evaluation methods and explored their respective relationships with the patient baseline clinical status and outcome 12months after surgery. This was a retrospective analysis of prospectively collected data from 157 patients (88 male, 69 female; age 72±7years) who were undergoing first-time surgery for LSS. Patients with foraminal or isolated lateral stenosis were excluded. The Core Outcome Measures Index (COMI) was completed before and 12months after surgery. Preoperative T2 axial MRIs were blinded and independently evaluated for DCSA and morphological grade. Spearman rank correlation coefficients described the relationship between the two MRI measures of stenosis severity and between each of these and the COMI baseline and change-scores (pre to 12months' postop). Multiple logistic regression analysis (controlling for baseline COMI, age, gender, number of operated levels, health insurance status) was used to analyse the influence of stenosis severity on the achievement of the minimum clinically important change (MCIC) score for COMI and on global treatment outcome (GTO). There was a correlation of ρ=-0.69 (p<0.001) between DCSA and morphological grade. There was no significant correlation between COMI baseline scores and either DCSA or morphological grades (p>0.85). However, logistic regression revealed significant (p<0.05) associations between stenosis ratings and 12-month outcome, whereby patients with more severe stenosis (as measured using either of the methods) benefited more from the surgery. Patients with a DCSA <75mm2 or morphological grade D had a 4-13-fold greater odds of achieving the MCIC for COMI or a "good" GTO, compared with patients in the least severe categories of stenosis. Postoperative outcome was clearly related to the degree of preoperative radiological LSS. The two MRI methods appeared to deliver similar information, as given by the relatively strong correlation between them and their comparable performance in relation to baseline and 12-month outcomes. However, the qualitative morphological grading can be performed in an instant, without measurement tools, and does not deliver less clinically useful information than the more complex and time-consuming measures; as such, it may represent the preferred method in the clinical routine for assessing the extent of radiological stenosis and the likelihood of a positive outcome after decompression.

Cross-cultural adaptation and validation of the Dutch version of the core outcome measures index for low back pain.

The core outcome measures index (COMI) is a validated multidimensional instrument for assessing patient-reported outcome in patients with back problems. The aim of the present study is to translate the COMI into Dutch and validate it for use in native Dutch speakers with low back pain. The COMI was translated into Dutch following established guidelines and avoiding region-specific terminology. A total of 89 Dutch-speaking patients with low back pain were recruited from 8 centers, located in the Dutch-speaking part of Belgium. Patients completed a questionnaire booklet including the validated Dutch version of the Roland Morris disability questionnaire, EQ-5D, the WHOQoL-Bref, the Numeric Rating Scale (NRS) for pain, and the Dutch translation of the COMI. Two weeks later, patients completed the Dutch COMI translation again, with a transition scale assessing changes in their condition. The patterns of correlations between the individual COMI items and the validated reference questionnaires were comparable to those reported for other validated language versions of the COMI. The intraclass correlation for the COMI summary score was 0.90 (95% CI 0.84-0.94). It was 0.75 and 0.70 for the back and leg pain score, respectively. The minimum detectable change for the COMI summary score was 1.74. No significant differences were observed between repeated scores of individual COMI items or for the summary score. The reproducibility of the Dutch translation of the COMI is comparable to that of other validated spine outcome measures. The COMI items correlate well with the established item-specific scores. The Dutch translation of the COMI, validated by this work, is a reliable and valuable tool for spine centers treating Dutch-speaking patients and can be used in registries and outcome studies.

Chronic pain and quality of life after inguinal hernia repair using the COMI-hernia score.

The Core Outcome Measure Index (COMI) is a brief and multidimensional, patient-orientated outcome questionnaire that assesses chronic pain and quality of life after groin hernia repair. The primary aim of this study was to prospectively assess the COMI-hernia score, over an extended period of time in a single large cohort of patients. Two hundred and twenty-eight male patients with inguinal hernia repair were included in the present study. Patients were recruited prospectively with an average follow-up of 3years. COMI-hernia total and the COMI-hernia pain scores were significantly lower following surgery and remained unchanged over time. Young patients' age (p=0.043), high preoperative COMI-hernia total score (p=0.018), and bilateral hernias (p=0.035) were identified as independent risk factors for adverse outcome after groin hernia repair. Both COMI-hernia total and the COMI-hernia pain scores significantly (p<2.2*10-16 and p<1.638*10-11) correlated with patient's satisfaction. The COMI score reflects a reliable tool to assess the outcome following groin hernia repair.

Quality of Life and Functional Outcome after Microsurgical Decompression in Lumbar Spinal Stenosis: a Register Study

Introduction Because of recent increases in life expectancy, lumbar spinal stenosis (LSS) has become one of the most common degenerative changes in the spine. In patients not responding to conservative therapy, microsurgical decompression is the gold standard of operative treatment for degenerative LSS. The goal of the current study is to evaluate quality of life after microsurgical decompression for LSS, using data from the DWG Register (previously Spine Tango). Methods 36 patients were included in this single-center, prospective, observational study from January 2013 to June 2014. Data were collected from the Spine Tango or DWG Register. The core outcome measure index (COMI), Oswestry Disability Index (ODI), and the quality of life questionnaire EuroQoL-5D were used. Data were collected prior to surgery as well as six weeks, six months, and twelve months after the operation. Results The patient cohort comprised 13 females and 23 males (36.1 and 63.9 %). Complete 12-month follow-up data on 21 patients were available for analysis. Compared to preoperative measures, the COMI score increased 8.1 ± 1.5 over the entire follow up, with 4.5 ± 3.1 at 6 weeks (p < 0.001), 4.8 ± 3.1 at 6 months, and 3.8 ± 3.2 at 12 months. ODI scores, measuring spinal function impairment, were significantly better than preoperative values overall (47.5 ± 17.3) and after 6 weeks (29.1 ± 22.4; p < 0.005), 6 months (30.0 ± 19.3), and 12 months (23.8 ± 18.2). Quality of life measures improved in a similar manner (preoperative: 0.36 ± 0.38; 6 weeks: 0.57 ± 0.34 (p < 0.019); 6 months: 0.62 ± 0.28; 12 months: 0.67 ± 0.31). Conclusion Our study shows that LSS patients without previous surgery and neurologic deficits can expect significant pain relief and improved quality of life already six weeks after undergoing stabilizing decompression. There was an increase in positive postoperative effects over 12 months. The DWG Register provides a standardized and validated means to compare non-operative and operative treatments of the spine over the long term.

Comparison of minimally invasive spine surgery using intraoperative computed tomography integrated navigation, fluoroscopy, and conventional open surgery for lumbar spondylolisthesis: a prospective registry-based cohort study

Background ContextTo date, the surgical approaches for the treatment of lumbar spondylolisthesis by transforaminal lumbar interbody fusion (TLIF) using minimally invasive spine surgery assisted with intraoperative computed tomography image-integrated navigation (MISS-iCT), fluoroscopy (MISS-FS), and conventional open surgery (OS) are debatable. PurposeThis study compared TLIF using MISS-iCT, MISS-FS, and OS for treatment of one-level lumbar spondylolisthesis. Study DesignThis is a prospective, registry-based cohort study that compared surgical approaches for patients who underwent surgical treatment for one-level lumbar spondylolisthesis. Patient SampleOne hundred twenty-four patients from January 2010 to March 2012 in a medical center were recruited. Outcome MeasuresThe outcome measures were clinical assessments, including Short-Form 12, visual analog scale (VAS), Oswestry Disability Index, Core Outcome Measurement Index, and patient satisfaction, and blood loss, hospital stay, operation time, postoperative pedicle screw accuracy, and superior-level facet violation. MethodsAll surgeries were performed by two senior surgeons together. Ninety-nine patients (40M, 59F) who had at least 2 years' follow-up were divided into three groups according to the operation methods: MISS-iCT (N=24), MISS-FS (N=23), and OS (N=52) groups. Charts and surgical records along with postoperative CT images were assessed. ResultsMISS-iCT and MISS-FS demonstrated a significantly lowered blood loss and hospital stay compared with OS group (p<.01). Operation time was significantly lower in the MISS-iCT and OS groups compared with the MISS-FS group (p=.002). Postoperatively, VAS scores at 1 year and 2 years were significantly improved in the MISS-iCT and MISS-FS groups compared with the OS groups. No significant difference in the number of pedicle screw breach (>2 mm) was found. However, a lower superior-level facet violation rate was observed in the MISS-iCT and OS groups (p=.049). ConclusionsMISS-iCT TLIF demonstrated reduced operation time, blood loss, superior-level facet violation, hospital stay, and improved functional outcomes compared with the MISS-FS and OS approaches.

Does pre-operative magnetic resonance imaging of the lumbar multifidus muscle predict clinical outcomes following lumbar spinal decompression for symptomatic spinal stenosis?

To investigate whether pre-operative magnetic resonance imaging (MRI) of the lumbar multifidus muscle (LMM) would predict clinical outcomes following lumbar spinal decompression for symptomatic spinal stenosis. A prospective cohort of patients with symptomatic neurogenic claudication, documented spinal stenosis on pre-operative MRI underwent spinal decompression. All subjects completed standardised outcome measures (Core Outcome Measures Index (COMI), Oswestry Disability Index (ODI v2.1) pre-operatively, 1 and 2years post-surgery. Surgery was performed using a standardised lumbar spinous process osteotomy for access, followed by a decompression of the central canal, lateral recess and foraminal zones as indicated by the pre-operative MRI. Lumbar MRI scans were evaluated by two independent observers who assessed the axial CSA of the LMM bilaterally and the degree of muscle atrophy according to the Kader classification (2000). Changes in COMI and ODI scores at 1 and 2years were investigated for statistically significant correlations with CSA of LMM and Kader grading. Statistical analyses utilised Student's t test, kappa coefficient for inter-observer agreement and Bland-Altman Limits of Agreement (BALOA). 66 patients (41 female) aged between 29 and 86years underwent single-level decompression in 44, two-level decompression in 16 and three-level decompression in 6 cases. No significant correlation was observed between improvements in ODI and COMI relative to age, degree of stenosis, posterior fat thickness or psoas CSA. Those subjects with the greatest LMM atrophy relative to psoas CSA and L5 vertebral body area on pre-operative MRI had the least absolute improvement in both ODI and COMI scores (p=0.006). Reduced LMM CSA (<8.5cm2) and muscle atrophy were associated with less favourable outcomes following lumbar spinal decompression. Pre-operative CSA of LMM appeared to be a more reliable predictor of post-operative clinical outcomes compared to the Kader Grading Score. This is the first study to investigate the prognostic value of pre-operative MRI appearance and CSA of LMM with respect to post-operative outcome following lumbar decompression surgery. Healthy pre-operative LMM is associated with better outcomes following lumbar spinal decompression.

Outcome of L5 radiculopathy after reduction and instrumented transforaminal lumbar interbody fusion of high-grade L5-S1 isthmic spondylolisthesis and the role of intraoperative neurophysiological monitoring.

To evaluate the incidence and course of iatrogenic L5 radiculopathy after reduction and instrumented fusion of high-grade L5-S1 isthmic spondylolisthesis and the role of intraoperative neurophysiological monitoring (IONM). Consecutive patients treated for high-grade spondylolisthesis with IONM from 2005 to 2013 were screened for eligibility. Prospectively collected clinical and surgical data as well as radiographic outcomes were analyzed retrospectively. Patients completed the multidimensional Core Outcome Measures Index (COMI) before and at 3, 12, and 24months after surgery. Seventeen patients were included, with a mean age of 26.3 (±9.5) years. Mean preoperative L5-S1 slip was 72% (±21%) and was reduced to 19% (±13%) postoperatively. Mean loss of reduction at last follow-up [mean 19months (±14, range 3-48months)] was 3% (±4.3%). Rate of new L5 radiculopathy with motor deficit (L5MD) after surgery was 29% (five patients). Four patients fully recovered after 3months, one patient was lost to neurologic follow-up. IONM sensitivity and specificity for postoperative L5MD was 20 and 100%, respectively. COMI, back pain and leg pain scores showed significant (p<0.001) improvements at 3months postoperatively, which were retained up to 24months postoperatively. Transient L5 radiculopathy after reduction and instrumented fusion of high-grade spondylolisthesis is frequent. With IONM the risk of irreversible L5 radiculopathy is minimal. If IONM signal changes recover, full clinical recovery is expected within 3months. Overall, patient-reported outcome of reduction and instrumented fusion of high-grade spondylolisthesis showed clinically important improvement.

Preoperative sport improves the outcome of lumbar disc surgery: a prospective monocentric cohort study

A lumbar disc herniation resulting in surgery may be an incisive event in a patient’s everyday life. The patient’s recovery after sequestrectomy may be influenced by several factors. There is evidence that regular physical activity can lower pain perception and improve the outcome after surgery. For this purpose, we hypothesized that patients performing regular sports prior to lumbar disc surgery might have less pain perception and disability thereafter. Fifty-two participants with a single lumbar disc herniation confirmed on MRI treated by a lumbar sequestrectomy were included in the trial. They were categorized into two groups based on their self-reported level of physical activity prior to surgery: group NS, no regular physical activity and group S, with regular physical activity. Further evaluation included a detailed medical history, a physical examination, and various questionnaires: Visual Analog Scale (VAS), Beck-Depression-Inventory (BDI), Oswestry Disability Index (ODI), Core Outcome Measure Index (COMI), and the EuroQoL-5Dimension (EQ- 5D). Surgery had an excellent overall improvement of pain and disability (p < 0.005). The ODI, COMI, and EQ-5D differed 6 months after intervention (p < 0.05) favoring the sports group. Leg and back pain on VAS was also significantly less in group B than in group A, 12 months after surgery (p < 0.05). Preoperative regular physical activity is an important influencing factor for the overall satisfaction and disability after lumbar disc surgery. The importance of sports may have been underestimated for surgical outcomes.

Gender differences after lumbar sequestrectomy: a prospective clinical trial using quantitative sensory testing

BackgroundQuantitative sensory testing (QST) gained popularity to evaluate the time course of recovery in sensory dysfunction and the results of different treatment options. Concerning sex differences in lumbar spine surgery, female gender seems to play a major role as a negative prognostic factor in different spinal disorders. For this purpose, we hypothesised that there are also comparable differences in pain patterns in men and women after lumbar sequestrectomy using QST.MethodsWe applied the QST protocol of the German Research Network on Neuropathic Pain in 53 patients (21 women and 32 men) with a single lumbar disc herniation confirmed on MRI treated by a lumbar sequestrectomy. Further evaluation included a detailed medical history, a physical examination, and various questionnaires: Beck-Depression-Inventory, Oswestry Disability Index, Core Outcome Measure Index, painDETECT-Questionnaire and EQ-5D thermometer.ResultsOur analyses showed lower heat thresholds in females preoperatively, that adjusted to that of males 1 week postoperatively. Pressure pain thresholds were lower in women as well, but differed between genders throughout the study. Vibration perception deficits resolve earlier in female than in male patients. Both, women and men, had an excellent overall improvement, postoperatively.ConclusionOur results clearly revealed pre- and postoperative differences in pain perception between genders. These differences have to be taken into account in the evaluation of outcome between genders. Therefore, QST seems to be a good method to evaluate the time course of recovery after surgery.