Systematic review.
To identify, describe, and evaluate common outcome measures in patients with chronic low back pain (CLBP).
The treatment of CLBP has been associated with multiple clinical ...challenges. Further complicating this is the myriad of outcome scores used to assess treatment of CLBP. These scores have been used to examine different domains of patient satisfaction and quality of life in the literature. Critical assessment of the frequency, parity, and the quality of these outcomes are essential to improve our understanding of CLBP.
A systematic review of the English-language literature was undertaken for articles published from January 2001 through December 31, 2010. Electronic databases and reference lists of key articles were searched to identify measures used to evaluate outcomes in six different domains in patients with CLBP. The titles and abstracts of the peer-reviewed literature of LBP were searched to determine which of these measures were most commonly reported in the literature and which have been validated in populations with CLBP.
We identified 75 outcome measures cited to evaluate CLBP. Twenty-nine of these outcome measures were excluded because of only a single citation leaving 46 measures for the evaluation. The most commonly used functional outcomes were the Oswestry Disability Index, Roland Morris Disability Index, and range of motion. For pain, the Numeric Pain Rating Scale, Brief Pain Inventory, Pain Disability Index, McGill Pain Questionnaire, and visual analog scale were most commonly cited. For psychosocial function, the Fear Avoidance Beliefs Questionnaire, Tampa Scale for Kinesiophobia, and Beck Depression Inventory were most commonly used. For generic quality of life, short form 36, Nottingham Health Profile, short form 12, and Sickness Impact Profile were the most common measures. For objective measures, the work status/return to work, complications or adverse events, and medications used were the most commonly cited. For preference-based measures, the Euro-Quol 5 dimensions and short form 6 dimensions were most commonly cited. The validity, reliability, responsiveness, universality, and potential proprietary requirements are summarized for each.
Outcome measures should be routinely assessed in patients with CLBP. The choice of appropriate outcome measure should be influenced by the study objectives and design, as well as properties of the particular measure within the context of CLBP.
Recommendation 1: When selecting the appropriate outcome measures for clinical or research purposes, consider domains that best measure what are most important to patients. Measures that are valid, reliable, and responsive to change should be considered first. Other considerations include the number of items required (especially in the context of multiple measures), whether the measure is validated in the relevant language, and the associated costs or fees. Strength: Strong Recommendation 2: Domains of greatest importance include pain, function, and quality of life. If cost utilization is a priority, then preference-based measures should be considered. For pain, we recommend the VAS and NRPS because of their ease of administration and responsiveness. For function, we recommend the ODI and RMDQ. The SF-36 and its shorter versions are most commonly used and should be considered if quality of life is important. If cost utility is important, consider the EQ-5D or SF-6D. Psychosocial tests are best used as screening tools prior to surgery because of their lack of responsiveness. Complications should always be assessed as a standard of clinical practice. Return to work and medication use are complicated outcome measures and not recommended unless the specific study question is focused on these domains. Consider staff and patient burden when prioritizing one's battery of measures.
STUDY DESIGN.Narrative review.
OBJECTIVE.To identify suitable outcome measures that can be used to quantify neurological and functional impairment in the management of cervical spondylotic myelopathy ...(CSM).
SUMMARY OF BACKGROUND DATA.CSM is the leading cause of acquired spinal cord disability, causing varying degrees of neurological impairment which impact on independence and quality of life. Because this impairment can have a heterogeneous presentation, a single outcome measure cannot define the broad range of deficits seen in this population. Therefore, it is necessary to define outcome measures that characterize the deficits with greater validity and sensitivity.
METHODS.This review was conducted in 3 stages. Stage ITo evaluate the current use of outcome measures in CSM, PubMed was searched using the name of the outcome measure and the common abbreviation combined with “CSM” or “myelopathy.” Stage IIHaving identified a lack of appropriate outcome measures, we constructed criteria by which measures appropriate for assessing the various aspects of CSM could be identified. Stage IIIA second literature search was then conducted looking at specified outcomes that met these criteria. All literature was reviewed to determine specificity and psychometric properties of outcomes for CSM.
RESULTS.Nurick grade, modified Japanese Orthopaedic Association Scale, visual analogue scale (VAS) for pain, Short Form (36) Health Survey (SF-36), and Neck Disability Index were the most commonly cited measures. The Short-Form 36 Health Survey and Myelopathy Disability Index have been validated in the CSM population with multiple studies, whereas the modified Japanese Orthopaedic Association Scale score, Nurick grade, and European Myelopathy Scale each had only one study assessing psychometric characteristics. No validity, reliability, or responsiveness studies were found for the VAS or Neck Disability Index in the CSM population.
CONCLUSION.We recommend that the modified Japanese Orthopaedic Association Scale, Nurick grade, Myelopathy Disability Index, Neck Disability Index, and 30-Meter Walk Test are most appropriate for the assessment of CSM. However, 6 additional outcome measures (QuickDASH, Berg Balance Scale, Graded Redefined Assessment of Strength Sensibility and Prehension, Grip Dynamometer, and GAITRite Anlaysis) were identified, which provide complementary assessments for CSM.Summary Statements. There does not exist a single or composite of outcome instruments that measures myelopathy impairment, function/disability, and participation that have also demonstrated reliability, validity, and responsiveness in a CSM population. More work in the development and psychometric evaluation of new or existing measures is necessary to identify the ideal composite of measures to be used in the clinical and research settings.
STUDY DESIGN.Systematic review.
OBJECTIVE.We performed a systematic review to determine the comparative effectiveness and safety profiles of anterior versus posterior decompression procedures for ...multilevel cervical spondylotic myelopathy (CSM).
SUMMARY OF BACKGROUND DATA.CSM is a common cause of neurological dysfunction. It is well established that surgical decompression of the cervical spinal cord is an effective treatment option for CSM. Because of the lack of well-designed prospective studies, there remains a lack of consensus whether multilevel spondylotic compression is best treated via an anterior or posterior surgical route and whether one of these surgical approaches is superior in terms of patient outcomes and/or complication profiles.
METHODS.We conducted a systematic search for literature published through September 2012. We sought to identify comparative studies (e.g., randomized controlled trials, cohort studies) comparing anterior with posterior procedures in patients with 2-level or greater cord compression resulting in CSM. Standardized mean differences were calculated to allow comparisons of the change (i.e., improvement or decline) in scores between anterior and posterior surgical procedures by study. Clinical recommendations were made through a modified Delphi approach by applying the GRADE (Grading of Recommendation Assessment, Development and Evaluation)/AHRQ (Agency for Healthcare Research and Quality) criteria.
RESULTS.We identified 8 level III retrospective cohort studies that met the inclusion criteria from a total of 135 possible studies for review. With regard to effectiveness between the 2 approaches, improvements in JOA (Japanese Orthopaedic Association) scores were similar, whereas canal diameter change was larger after posterior surgery. With regard to safety, postoperative C5 palsy rates were similar, infection rates were lower with anterior surgery, and dysphagia rates were lower with posterior surgery.
CONCLUSION.This systematic review demonstrates that, for both effectiveness and safety, there is no clear advantage to either an anterior surgical approach or a posterior surgical approach when treating patients with multilevel CSM. With that, a surgical strategy developed on a patient-to-patient basis should be used to achieve optimal patient outcomes. In addition, development of a consensus for standardized reporting of outcome measures and complication profiles would facilitate improved comparisons across differing treatment centers and surgical techniques.Recommendation. We recommend an individualized approach when treating patients with CSM accounting for pathoanatomical variations (ventral vs. dorsal, focal vs. diffuse, sagittal, dynamic instability) because there are similar outcomes between the anterior and posterior approaches with regard to effectiveness and safety.Overall Strength of Evidence. LowStrength of Recommendation. Strong
A systematic review of the literature.
To compare total disc replacement (TDR) with fusion, other motion-sparing devices with fusion, and motion-sparing devices with other motion-sparing devices to ...determine which devices may be associated with a lower risk of radiographical or clinical adjacent segment pathology (ASP).
Adjacent segment pathology, also termed adjacent segment disease (ASD) or adjacent segment degeneration, is a controversial phenomenon that can occur after a spinal fusion; it is thought to be either related to the altered mechanics or loss of motion from the fusion or to be part of the natural history of progressive arthritis. Motion preservation devices theoretically may decrease or prevent ASP from occurring.
A systematic search was conducted in PubMed and the Cochrane Library for literature published between January 1990 and February 2012. For all key questions, we identified all cohort studies and randomized controlled trials, making the comparison of interest independent of the outcomes measured. We searched each full-text article to determine whether it reported any type of structural or degenerative condition specifically occurring at an adjacent segment. We included articles reporting adult lumbar patients who had degenerative disc disease, disc herniation, radiculopathy, kyphosis, scoliosis, and spondylolisthesis, and who were treated with TDR, other motion-sparing procedures, or fusion. The overall strength of the evidence for each key question was rated using the Grades of Recommendation Assessment, Development and Evaluation (GRADE) criteria.
There is moderate evidence to suggest that patients who undergo fusion may be nearly 6 times more likely to be treated for ASP than those who undergo TDR. From 2 randomized trials, the pooled risk of clinical ASP treated surgically was 1.2% and 7.0% in the TDR and fusion groups, respectively (P = 0.009). The increased risk of clinical ASP treated surgically associated with fusion is 5.8%. For every 17 operations, one might expect a new clinical ASP event requiring surgery when treated with fusion in those otherwise not harmed by TDR. There was insufficient literature to answer the other key questions, resulting in low to insufficient evidence that other motion-sparing operations are superior to fusion in preventing clinical ASP.
There does seem to be a low rate of ASP after lumbar spinal fusion. The evidence suggests that the risk of clinical ASP following fusion is higher when compared with TDR, but there is limited evidence that fusion may increase the risk of developing clinical ASP compared with other motion-sparing procedures.
1. Evidence demonstrates that the risk of clinical ASP requiring surgery is likely greater after fusion but the risk is still quite rare. The increased risk compared to TDR could be as small as less than 1% or as great as 10%. Strength of Statement: Weak. 2. There is insufficient evidence to make a definitive statement regarding fusion versus other motion-sparing devices with respect to the risk of ASP.
STUDY DESIGN.Systematic review.
OBJECTIVE.The primary objectives of this review were to compare the effectiveness and safety of various anterior cervical decompressive and reconstructive procedures ...for diffuse or multifocal cervical spondylotic myelopathy (CSM). An additional objective was to describe the most common ancillary stabilization techniques used with the different anterior decompressive procedures.
SUMMARY OF BACKGROUND DATA.Surgical management of CSM provides for neurological recovery and disease stabilization in a cost-effective way. Although both retrospective and prospective data support management of CSM by anterior cervical decompression and fusion, the choice decision between various anterior surgical options remains unclear.
METHODS.We conducted a systematic search in MEDLINE and the Cochrane Collaboration Library for human studies in the English-language literature published through September 2012. We included studies comparing multiple discectomies with single or multiple corpectomy, multiple discectomies with discectomy-corpectomy hybrid, and multiple corpectomies with discectomy-corpectomy hybrid, comparing effectiveness and safety outcomes of each procedure, and defining the ancillary stabilization techniques used. Exclusion criteria included patients with degenerative disc disease or degenerative joint disease without CSM, single-level CSM, ossified posterior longitudinal ligament (OPLL), spinal tumor, concomitant infection, and ankylozing spondylitis. Case series, case reports, data not reported separately for each comparison group, or studies that consisted of an N less than 10 for either comparison group were excluded. The evidence strength was rated using the GRADE (Grades of Recommendation Assessment, Development, and Evaluation) criteria.
RESULTS.Of the 49 citations identified from our search, 10 studies were initially found suitable for inclusion. Patients undergoing any of the 3 procedures generally experienced improvements in clinical outcomes (neck disability index, Japanese Orthopaedic Association score, and Visual Analogue Scale score for pain) as well as overall sagittal alignment, with minimal perioperative morbidity. There is moderate evidence supporting selection of multiple discectomies compared with corpectomy or discectomy-corpectomy hybrid procedures with regard to superior clinical outcomes and postoperative sagittal alignment. Furthermore, if more extensive operation is needed, there is evidence to support the selection of discectomy-corpectomy hybrid procedures compared with multiple corpectomies if it is technically feasible to accomplish the requisite decompression. The multiple discectomies approach also may have a lower incidence of C5 palsy than corpectomy or discectomy-corpectomy hybrid approaches.
CONCLUSION.All 3 operative approaches are effective strategies for the anterior surgical management of CSM. When the patient pathoanatomy permits, selection of multiple discectomies is favored compared with corpectomy or discectomy-corpectomy hybrid approaches.Recommendation 1. When pathoanatomically appropriate with minimal retrovertebral disease, we recommend the selection of multiple discectomy over corpectomy or discectomy-corpectomy hybrid procedures.Overall Strength of Evidence. LowStrength of Recommendation. StrongRecommendation 2. When retrovertebral disease is significant, we recommend, when possible, that discectomy-corpectomy hybrid procedures be performed instead of multiple corpectomies.Overall Strength of Evidence. ModerateStrength of Recommendation. StrongSummary Statements. There is no evidence to guide choice of ancillary external immobilization techniques following multilevel anterior decompression and fusion procedures for CSM.
Systematic review.
The objectives of this systematic review were to determine whether fusion is superior to conservative management in certain psychological subpopulations and to determine the most ...common psychological screening tests and their ability to predict outcome after treatment in patients with chronic lower back pain.
Many studies have documented the effects of various psychological disorders on outcomes in the treatment of lower back pain. The question of whether patients with certain psychological disorders would benefit more from conservative treatment than fusion is not clear. Furthermore, the most appropriate screening tools for assessing psychological factors in the presence of treatment decision making should be recommended.
Systematic review of the literature, focused on randomized controlled trials to assess the heterogeneity of treatment effect of psychological factors on the outcomes of fusion versus nonoperative care of the treatment of chronic low back pain. In the analysis of psychological screening tests, we searched for the most commonly reported questionnaires and those that had been shown to predict lower back pain treatment outcomes.
Few studies comparing fusion to conservative management reported differences in outcome by the presence or absence of a psychological disorder. Among those that did, we observed the effect of fusion compared with conservative management was more favorable in patients without a personality disorder, neuroticism, or depression. The most commonly reported, validated psychological screening tests for lower back pain are the Beck Depression Inventory, the Fear Avoidance Belief Questionnaire, the Spielberger Trait Anxiety Inventory, the Zung Depression Scale, and the Distress Risk Assessment Method.
Psychological disorders affect chronic lower back pain treatment outcomes. Patients with a personality disorder appear to respond more favorably to conservative management and those without a personality disorder more favorably to fusion. Patients with higher depression and neuroticism scores may also respond more favorably to conservative management.
Recommendation 1: Chronic LBP patients with depression, neuroticism, and certain personality disorders should preferentially be treated nonoperatively. Strength of recommendation: Weak. Recommendation 2: Consider the use of a validated psychological screening questionnaire such as the BDI, FABQ, DRAM, ZDI or STAI, when treating patients with CLBP. Strength of recommendation: Weak.
Study Design
Systematic review.
Clinical Questions
(1) Has the proportion and number of randomized controlled trials (RCTs) as an indicator of quality of evidence regarding lumbar fusion increased ...over the past 10 years? (2) Is there a difference in the proportion of RCTs among the four primary fusion diagnoses (degenerative disk disease, spondylolisthesis, deformity, and adjacent segment disease) over the past 10 years? (3) Is there a difference in the type and quality of clinical outcomes measures reported among RCTs over time? (4) Is there a difference in the type and quality of adverse events measures reported among RCTs over time? (5) Are there changes in fusion surgical approach and techniques over time by diagnosis over the past 10 years?
Methods
Electronic databases and reference lists of key articles were searched from January 1, 2004, through December 31, 2013, to identify lumbar fusion RCTs. Fusion studies designed specifically to evaluate recombinant human bone morphogenetic protein-2 or other bone substitutes, revision surgery studies, nonrandomized comparison studies, case reports, case series, and cost-effectiveness studies were excluded.
Results
Forty-two RCTs between January 1, 2004, and December 31, 2013, met the inclusion criteria and form the basis for this report. There were 35 RCTs identified evaluating patients diagnosed with degenerative disk disease, 4 RCTs evaluating patients diagnosed with degenerative spondylolisthesis, and 3 RCTs evaluating patients with a combination of degenerative disk disease and degenerative spondylolisthesis. No RCTs were identified evaluating patients with deformity or adjacent segment disease.
Conclusions
This structured review demonstrates that there has been an increase in the available clinical database of RCTs using patient-reported outcomes evaluating the benefit of lumbar spinal fusion for the diagnoses of degenerative disk disease and degenerative spondylolisthesis. Gaps remain in the standardization of reportage of adverse events in such trials, as well as uniformity of surgical approaches used. Finally, continued efforts to develop higher-quality data for other surgical indications for lumbar fusion, most notably in the presence of adult spinal deformity and revision of prior surgical fusions, appear warranted.
Terminology Anderson, Paul A; Andersson, Gunnar B J; Arnold, Paul M ...
Spine (Philadelphia, Pa. 1976),
10/2012, Volume:
37, Issue:
22 Suppl
Journal Article
Abstract
Study Design
Systematic review.
Study Rationale
One of the most consistent indications for a Chiari decompression is tonsillar descent meeting the radiographic criteria and an associated ...syrinx in a symptomatic patient. In counseling patients about surgery, it would be advantageous to have information regarding the expected outcome with regard to the syrinx and other possible treatments available if the result is suboptimal.
Clinical Questions
The clinical questions include: (1) What is the average rate of recurrent or residual syringomyelia following posterior fossa decompression as a result of Chiari malformation with associated syringomyelia? (2) What treatment methods have been reported in the literature for managing recurrent or residual syringomyelia after initial posterior fossa decompression?
Materials and Methods
Available search engines were utilized to identify publications dealing with recurrent or residual syrinx after Chiari decompression and/or management of the syrinx. Rates of residual or recurrent syrinx were extracted and management strategies were recorded. Overall strength of evidence was quantified.
Results
Of the 72 citations, 11 citations met inclusion criteria. Rates of recurrent/residual syringomyelia after decompression in adults range from 0 to 22% with an average of 6.7%. There were no studies that discussed specifically management of the remaining syrinx.
Conclusion
Rates of recurrent/residual syringomyelia after Chiari decompression in adults range from 0 to 22% (average 6.7%). Although no studies describing the optimal management of residual syrinx were found, there is general agreement that the aim of the initial surgery is to restore relatively unimpeded flow of cerebrospinal across the craniocervical junction. Large holocord syrinx may induce a component of spinal cord injury even with adequate decompression and reduction in the caliber of the syrinx, resulting in permanent symptoms of injury.
PDF
