The impact of economic evaluation on quality management in spine surgery

Health care expenditures are substantially increasing within the last two decades prompting the imperative need for economic evaluations in health care. Historically, economic evaluations in health care have been carried out by four approaches: (1) the human-capital approach (HCA), (2) cost-effectiveness analysis (CEA), (3) cost-utility analysis (CUA) and (4) cost-benefit analysis (CBA). While the HCA cannot be recommended because of methodological shortcomings, CEA and CUA have been used frequently in healthcare. In CEA, costs are measured in monetary terms and health effects are measured in a non-monetary unit, e.g. number of successfully treated patients. In an attempt to develop an effectiveness measure that incorporates effects on both quantity and quality of life, so-called Quality Adjusted Life Years (QUALYs) were introduced. Contingent valuation surveys are used in cost-benefit analyses (CBA) to elicit the consumer's monetary valuations for program benefits by applying the willingness-to-pay approach. A distinguished feature of CBA is that costs and benefits are expressed in the same units of value, i.e. money. Only recently, economic evaluations have started to explore various spinal interventions particularly the very expensive fusion operations. While most of the studies used CEA or CUA approaches, CBAs are still rare. Most studies fail to show that sophisticated spinal interventions are more cost-effective than conventional treatments. In spite of the lack of therapeutic or cost-effectiveness for most spinal surgeries, there is rapidly growing spinal implant market demonstrating market imperfection and information asymmetry. A change can only be anticipated when physicians start to focus on the improvement of health care quality as documented by outcome research and economic evaluations of cost-effectiveness and net benefit

Biological treatment strategies for disc degeneration: potentials and shortcomings

Recent advances in molecular biology, cell biology and material sciences have opened a new emerging field of techniques for the treatment of musculoskeletal disorders. These new treatment modalities aim for biological repair of the affected tissues by introducing cell-based tissue replacements, genetic modifications of resident cells or a combination thereof. So far, these techniques have been successfully applied to various tissues such as bone and cartilage. However, application of these treatment modalities to cure intervertebral disc degeneration is in its very early stages and mostly limited to experimental studies in vitro or in animal studies. We will discuss the potential and possible shortcomings of current approaches to biologically cure disc degeneration by gene therapy or tissue engineering. Despite the increasing number of studies examining the therapeutic potential of biological treatment strategies, a practicable solution to routinely cure disc degeneration might not be available in the near future. However, knowledge gained from these attempts might be applied in a foreseeable future to cure the low back pain that often accompanies disc degeneration and therefore be beneficial for the patien

Must we discontinue selective cervical nerve root blocks?: Report of two cases and review of the literature

We report two detrimental neurologic complications after technically correct selected cervical nerve root blocks. Based on these cases and a thorough review of the literature, the indication for cervical nerve root blocks was reconsidered and limited. Similarly, we modified our technique to further reduce the likelihood for the occurrence of such severe complication

Matrix metalloproteinase expression levels suggest distinct enzyme roles during lumbar disc herniation and degeneration

The disruption of the extracellular disc matrix is a major hallmark of disc degeneration. This has previously been shown to be associated with an up-regulation of major matrix metalloproteinase (MMP) expression and activity. However, until now hardly any data are available for MMP/TIMP regulation and thereby no concept exists as to which MMP/TIMP plays a major role in disc degeneration. The objective of this study was, therefore, to identify and quantify the putative up-regulation of MMPs/TIMPs on the mRNA and protein level and their activity in disc material in relation to clinical data and histological evidence for disc degeneration. A quantitative molecular analysis of the mRNA expression levels for the MMPs (MMPs-1, -2, -3, -7, -8, -9, -13) and the MMP inhibitors (TIMPs-1 and -2) was performed on 37 disc specimens obtained from symptomatic disc herniation or degeneration. In addition, disc specimens from patients without disc degeneration/herniation (=controls) were analyzed. Expression of MMPs-1, -2, -3, -7, -8, -9, -13 and TIMPs-1, -2 was analyzed using quantitative RT-PCR, normalized to the expression level of a house keeping gene (GAPDH). Gene expression patterns were correlated with MMP activity (in situ zymography), protein expression patterns (immunohistochemistry), degeneration score (routine histology) and clinical data. MMP-3 mRNA levels were consistently and substantially up-regulated in samples with histological evidence for disc degeneration. A similar but less pronounced up-regulation was observed for MMP-8. This up-regulation was paralleled by the expression of TIMP-1 and to a lesser extent TIMP-2. In general, these findings could be confirmed with regard to protein expression and enzyme activity. This study provides data on the gene and protein level, which highlights the key role of MMP-3 in the degenerative cascade leading to symptomatic disc degeneration and herniation. Control of the proteolytic activity of MMP-3 may, therefore, come into the focus when aiming to develop new treatment options for early disc degeneratio

Outcome assessment in low back pain: how low can you go?

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 6months 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 1-2weeks. 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 system

Imaging findings predicting the outcome of cervical facet joint blocks

To determine which cross-sectional imaging findings predict the short-term outcome of cervical facet joint blocks (FJB) and to evaluate the effect of combined intra-/periarticular versus periarticular injection on pain. Fifty facet joints in 37 patients were included in the study. Single, unilateral FJBs in 24 patients, and bilateral single level FJBs in 13 patients were performed, respectively. In all patients, pain relief was assessed using a visual analogue scale. All computed tomography (CT) examinations were blindly reviewed by two radiologists. Osteoarthritis was rated using the Kellgren classification. The presence of combined intra-/periarticular vs. sole periarticular injection of contrast was evaluated. Kellgren Grades 0 (n=23), 1 (n=5), 2 (n=3), 3 (n=9), and 4 (n=10) were found. Mean pain relief after injection was 35% (range: 0-100%). 40% of all injections were combined intra-/periarticular. There was neither a statistically significant difference between pain relief and combined intra-/periarticular versus sole periarticular injection (p=0.64) nor the grade of osteoarthritis (p=0.49). Pain relief after cervical FJBs does not correlate with morphologic alterations seen on CT. Periarticular FJBs are not less successful than combined intra-/periarticular FJB

Longitudinal validation of the Fear-Avoidance Beliefs Questionnaire (FABQ) in a Swiss-German sample of low back pain patients

Work and activity-specific fear-avoidance beliefs have been identified as important predictor variables in relation to the development of, and treatment outcome for, chronic low back pain. The objective of this study was to provide a cross-cultural German adaptation of the Fear-Avoidance Beliefs Questionnaire (FABQ) and to investigate its psychometric properties (reliability, validity) and predictive power in a sample of Swiss-German low back pain patients. Questionnaires from 388 operatively and non-operatively treated patients were administered before and 6months after treatment to assess: socio-demographic data, disability (Roland and Morris), pain severity, fear-avoidance beliefs, depression (ZUNG) and heightened somatic awareness (MSPQ). Complete baseline and follow-up questionnaires were available from 255 participants. The corrected item-total correlations, coefficients of test-retest reliability and internal consistencies of the two scales of the questionnaire were highly satisfactory. In a confirmatory factor analysis (CFA), all items loaded on the appropriate factor with minor loadings on the other. Cross-sectional regression analysis with disability and work loss as the dependent variables yielded results that were highly comparable with those reported for the original version. Prognostic regression analysis replicated the findings for work loss. The cross-cultural German adaptation of the FABQ was very successful and yielded psychometric properties and predictive power of the scales similar to the original version. The inclusion of fear-avoidance beliefs as predictor variables in studies of low back pain is highly recommended, as they appear to have unique predictive power in analyses of disability and work los

Improved 6-year overall survival in AT/RT - results of the registry study Rhabdoid 2007

Atypical teratoid rhabdoid tumors (AT/RT) are characterized by mutations and subsequent inactivation of SMARCB1 (INI1, hSNF5), a predilection for very young children and an unfavorable outcome. The European Registry for rhabdoid tumors (EU-RHAB) was established to generate a common European database and to establish a standardized treatment regimen as the basis for phase I/II trials. Thus, genetic analyses, neuropathologic and radiologic diagnoses, and a consensus treatment regimen were prospectively evaluated. From 2005 to 2009, 31 patients with AT/RT from four countries were recruited into the registry study Rhabdoid 2007 and treated with systemic and intraventricular chemotherapy. Eight patients received high-dose chemotherapy, 23 radiotherapy, and 17 maintenance therapy. Reference evaluations were performed in 64% (genetic analyses, FISH, MLPA, sequencing) up to 97% (neuropathology, INI1 stain). Germ-line mutations (GLM) were detected in 6/21 patients. Prolonged overall survival was associated with age above 3years, radiotherapy and achievement of a complete remission. 6-year overall and event-free survival rates were 46% (+/- 0.10) and 45% (+/- 0.09), respectively. Serious adverse events and one treatment-related death due to insufficiency of a ventriculo peritoneal shunt (VP-shunt) and consecutive herniation were noted. Acquisition of standardized data including reference diagnosis and a standard treatment schedule improved data quality along with a survival benefit. Treatment was feasible with significant but manageable toxicity. Although our analysis is biased due to heterogeneous adherence to therapy, EU-RHAB provides the best available basis for phase I/II clinical trials