In a prospective observational study we compared the two-year outcome of lumbar fusion by a simple technique using translaminar screws (n = 57) with a more extensive method using transforaminal lumbar interbody fusion and pedicular screw fixation (n = 63) in consecutive patients with degenerative disease of the lumbar spine. Outcome was assessed using the validated multidimensional Core Outcome Measures Index. Blood loss and operating time were significantly lower in the translaminar screw group (p < 0.01). The complication rates were similar in each group (2% to 4%). In all, 91% of the patients returned their questionnaire at two-years. The groups did not differ in Core Outcome Measures Index score reduction, 3.6 (sd 2.5) (translaminar screws) vs 4.0 (sd 2.8) (transforaminal lumbar interbody fusion) (p = 0.39); 'good' global outcomes, 78% (translaminar screws) vs 78% (transforaminal lumbar interbody fusion) (p = 0.99) or satisfaction with treatment, 82% (translaminar screws) vs 86% (transforaminal lumbar interbody fusion) (p = 0.52). The two fusion techniques differed markedly in their extent and the cost of the implants, but were associated with almost identical patient-orientated outcomes. Extensive three-point stabilisation is not always required to achieve satisfactory patient-orientated results at two years.
Studies comparing the relative merits of microdiscectomy and standard discectomy report conflicting results, depending on the outcome measure of interest. Most trials are small, and few have employed validated, multidimensional patient-orientated outcome measures, considered essential in outcomes research. In the present study, data were collected prospectively from six surgeons participating in a surgical registry. Inclusion criteria were: lumbar/lumbosacral degenerative disease; discectomy/sequestrectomy without additional fusion/stabilisation; German or English-speaking. Before and 3 and 12 months after surgery, patients completed the Core Outcome Measures Index comprising questions on leg/buttock pain, back pain, back-related function, symptom-specific well-being, general quality-of-life, and social and work disability. At follow-up, they rated overall satisfaction, global outcome, and perceived complications. Compliance with the registry documentation was excellent: 87% for surgeons (surgery forms), 91% for patients (for 12 months follow-up). 261 patients satisfied the inclusion criteria (225 microdiscectomy, 36 standard discectomy). The standard discectomy group had significantly greater blood-loss than the microdiscectomy (P < 0.05). There were no group differences in the proportion of surgical complications or duration of hospital stay (P > 0.05). The groups did not differ in relation to any of the patient-orientated outcomes or individual outcome domains (P > 0.05). Though not equivalent to an RCT, the study included every single eligible patient in our Spine Center and allowed surgeons to use their regular procedure; it hence had extremely high external validity (relevance/generalisability). There was no clinically relevant difference in outcome after lumbar disc excision dependent on the use of the microscope. The decision to use the microscope should rest with the surgeon.
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 ≥2.2 points decrease (sensitivity 81%, specificity 83%) and ≥0.3 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.
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 treatment of metastatic spinal cord compression is complex. The three treatment modalities that are currently applied (in a histologically non-specific manner) are surgery, radiotherapy and the administration of steroids. The development of new spinal instrumentations and surgical approaches considerably changed the extent of therapeutic options in this field. These new surgical techniques have made it possible to resect these tumours totally, with subsequent vertebral reconstruction and spinal stabilization. In this respect, it is important to clearly identify those patients who can benefit from such an extensive surgery. We present our management algorithm to help select patients for surgery and at the same time identifying those for whom primary non-surgical therapy would be indicated. The retrospective review of surgically treated patients in our department in the last four years reveals a meagre application of conventional guidelines for the selection of the appropriate operative approach in the surgical management of these patients. The reasons for this discrepancy are discussed.