Daniel C Norvell

Avoiding wrong site surgery: a systematic review.

Study Design. Systematic review. Objective. To report the incidence and causes of wrong site surgery and determine what preoperative measures are effective in preventing wrong site surgery. Summary of Background Data. From 1995 to 2005, the Joint Commission (JC) sentinel event statistics database ranked wrong site surgery as the second most frequently reported event with 455 of 3548 sentinel events (12.8%). Although the event seems to be rare, the incidence of these complications has been difficult to measure and quantify. The implications for wrong site surgery go beyond the effects to the patient. Such an event has profound medical, legal, social, and emotional implications. Methods. A systematic review of the English language literature was undertaken for articles published between 1990 and December 2008. Electronic databases and reference lists of key articles were searched to identify the articles defining wrong site surgery and reporting wrong site events. Two independent reviewers assessed the level of evidence quality using the Grading of Recommendations Assessment, Development, and Evaluation criteria and disagreements were resolved by consensus. Results. The estimated rate of wrong site surgery varies widely ranging from 0.09 to 4.5 per 10,000 surgeries performed. There is no literature to substantiate the effectiveness of the current JC Universal Protocol in decreasing the rate of wrong site, wrong level surgery. Conclusion. Wrong site surgery may be preventable. We suggest that the North American Spine Society and JC checklists are insufficient on their own to minimize this complication. Therefore, in addition to these protocols, we recommend intraoperative imaging after exposureand marking of a fixed anatomic structure. This imaging should be compared with routine preoperative studies to determine the correct site for spine surgery.

Evaluating common outcomes for measuring treatment success for chronic low back pain

Study Design. Systematic review. Objective. To identify, describe, and evaluate common outcome measures in patients with chronic low back pain (CLBP). Summary of Background Data. 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. Methods. 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. Results. 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. Conclusion. 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. Clinical Recommendations. 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 ones battery of measures.

The influence of perioperative risk factors and therapeutic interventions on infection rates after spine surgery: a systematic review.

Study Design. Systematic review. Objective. The objectives of this systematic review were to determine the patient and perioperative risk factors that contribute to infections after spine surgery and to examine the level of evidence to support the use of therapeutic interventions to reduce infection rates. Summary of Background Data. Infection continues to be one of the most common and feared complications after spine surgery. As such, it is used as a sentinel event for quality assurance processes. It is clear that the causes of infections after spine surgery are multifactorial and numerous patient- and procedure-related factors have been proposed as contributory elements. In addition, numerous perioperative adjuncts have been suggested to reduce infection rates. Methods. A systematic review of the English-language literature (published between January 1990 and June 2009) was undertaken to identify articles examining risk factors associated with and adjunct treatment measures for preventing surgical-site infections. Two independent reviewers assessed the level of evidence quality using the Grading of Recommendations Assessment, Development, and Evaluation criteria, and disagreements were resolved by consensus. Results. Of the 127 articles identified, 32 met the criteria to undergo full-text review. Individual patient, operative, and perioperative variables have been identified that are associated with increased infection rates (i.e., older age, obesity, diabetes, malnutrition, higher American Society of Anesthesiologists score, posterior approaches, and blood transfusions) but these variables have not been combined to provide individual patient risks based on a composite of factors (e.g., risk stratification). Of the surgical adjuncts investigated, only irrigation with dilute betadine solution showed moderate support for reducing infection rates. Conclusion. It is clear that the causes of postoperative spinal site infections are multifactorial and related to a complex interplay of patient and procedural influences. Because of these complexities, for any individual and surgical procedure, predictable infection rates likely exist that do not extrapolate to 0. Although we have identified factors associated with increased infection rates, further studies will be required to allow multifactorial risk stratification for individual patients and to further investigate the use of therapeutic adjuncts.

The evidence for intraoperative neurophysiological monitoring in spine surgery: Does it make a difference?

Objective. The objective of this article was to undertake a systematic review of the literature to determine whether IOM is able to sensitively and specifically detect intraoperative neurologic injury during spine surgery and to assess whether IOM results in improved outcomes for patients during these procedures. Summary and Background Data. Although relatively uncommon, perioperative neurologic injury, in particular spinal cord injury, is one of the most feared complications of spinal surgery. Intraoperative neuromonitoring (IOM) has been proposed as a method which could reduce perioperative neurologic complications after spine surgery. Methods. A systematic review of the English language literature was undertaken for articles published between 1990 and March 2009. MEDLINE, EMBASE, and Cochrane Collaborative Library databases were searched, as were the reference lists of published articles examining the use of IOM in spine surgery. Two independent reviewers assessed the level of evidence quality using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria, and disagreements were resolved by consensus. Results. A total of 103 articles were initially screened and 32 ultimately met the predetermined inclusion criteria. We determined that there is a high level of evidence that multimodal IOM is sensitive and specific for detecting intraoperative neurologic injury during spine surgery. There is a low level of evidence that IOM reduces the rate of new or worsened perioperative neurologic deficits. There is very low evidence that an intraoperative response to a neuromonitoring alert reduces the rate of perioperative neurologic deterioration. Conclusion. Based on strong evidence that multimodality intraoperative neuromonitoring (MIOM) is sensitive and specific for detecting intraoperative neurologic injury during spine surgery, it is recommended that the use of MIOM be considered in spine surgery where the spinal cord or nerve roots are deemed to be at risk, including procedures involving deformity correction and procedures that require the placement of instrumentation. There is a need to develop evidence-based protocols to deal with intraoperative changes in MIOM and to validate these prospectively.

Evaluating the Correlation and Responsiveness of Patient-reported Pain With Function and Quality-of-life Outcomes After Spine Surgery

Study Design. Systematic review. Objective. To determine the correlation of patient-reported pain with physical function and health-related quality of life (HRQoL) after spine surgery and to determine the responsiveness of pain, physical function, and HRQoL after spine surgery. Summary of Background Data. Several validated outcome instruments are available to assess the success of treatment for chronic low back pain. These patient-centered tools include measurements for pain based on numeric scales, validated condition-specific functional outcomes measures, and HRQoL outcomes measures. It is unclear whether these three types of patient-reported outcomes are measuring different constructs and whether all three should be measured after spine surgery. In addition, it is unclear which of these outcomes measures is most sensitive to change after spine surgery for low back pain. Methods. A systematic search was conducted in MEDLINE, EMBASE, and the Cochrane Collaboration Library for literature published through December 2010. The correlation between pain (visual analog scale, VAS), physical function (Oswestry Disability Index, ODI), and HRQoL (36-Item Short Form Health Survey [SF-36] and European Quality of Life [EQ-5D]) change scores was performed using the Spearman rank correlation coefficients. To compare the responsiveness of pain, function, and HRQoL scores after spine surgery, we calculated effect sizes by dividing change scores by the SD of the baseline scores. This standardized method allowed us to compare the responsiveness of each outcome measure directly and reported an effect size of 0.2 to 0.3 as a “small” effect, around 0.5 a “medium” effect and 0.8 to infinity, a “large” effect. To determine whether the differences in effect sizes measuring responsiveness were significantly different, we conducted a Wilcoxon signed-rank test between each of the three measurements of pain, function, and HRQoL scores when there was enough data to perform the test. Results. None of the correlations exceeded 0.70 using the Spearman rank correlation coefficients, suggesting that these outcomes are measuring different constructs. The strongest correlations were between the VAS back pain change scores and the SF-36 physical composite score change scores (&rgr; = 0.67) and VAS back pain change scores and ODI change scores (&rgr; = 0.69). The pooled mean effect sizes for the five studies that reported a pain measure and the ODI were 1.4 ± 0.57 and 1.1 ± 0.39, respectively. Both are considered “large” effect sizes. The pooled mean effect sizes for the three studies reporting the SF-36 physical and mental composite scores were 0.66 ± 0.39 and 0.54 ± 0.36, respectively. Both are considered “medium” effect sizes. The pooled mean effect sizes for the single studies reporting the EQ-5D and SF-36 total score were 0.78 ± 0.12 and 0.34 ± 0.21. These were “medium” and “small,” respectively. Conclusion. We observed little correlation between the change in pain and the change in HRQoL outcomes measures. The strongest correlation was between VAS pain and ODI but was still not considered strong (0.69). These findings suggest that these three outcomes (pain, function, and HRQoL) are measuring different constructs. With respect to responsiveness, VAS pain and ODI were the only outcomes measures that demonstrated a large effect after lumbar spine surgery. None of the HRQoL tools were as sensitive to the treatment. The EQ-5D, SF physical composite, and SF mental composite outcomes demonstrated a medium effect, while the SF-36 total score demonstrated a small effect. The responsive measure shows that the more specific the outcomes tool, the more sensitive the response. Clinical Recommendations. Recommendation 1: When surgically treating CLBP, we recommend administering both a VAS for pain and a condition-specific physical measure such as the ODI before and after surgical intervention as these outcomes are the most treatment specific and responsive to change. Strength of recommendation: Strong. Recommendation 2: When evaluating the surgical outcomes for CLBP in the clinical-research setting, we recommend selecting a shorter version for measuring general HRQoL (e.g., SF-12, EQ-5D) to minimize clinician and patient burden. Strength of recommendation: Strong.

Pharmacologic Management of Chronic Low Back Pain Synthesis of the Evidence

Study Design. Systematic review of the literature with subgroup analysis for heterogeneous treatment effects. Objective. The objectives of this systematic review were to summarize prior Cochrane reports regarding the safety and effectiveness of opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), and antidepressants for treatment of chronic low back pain (LBP) and to evaluate whether certain subpopulations respond more favorably to pharmacological management. Summary of Background Data. While medications are a mainstay of LBP management, there is uncertainty as to the optimal use of commonly prescribed medications such as opioids, antidepressants, and NSAIDS. Methods. To summarize the overall treatment effect and safety for each of the three pharmacological drug classes (opioids, NSAIDs, or antidepressants), we summarized existing Cochrane reviews. To evaluate whether the effects of treatment varied by specific subgroups of patients, we sought randomized controlled trials (RCTs) evaluating one of the three pharmacological drug classes versus an alternative management for chronic LBP. Results. Based on the Cochrane reviews, opioids are more effective than placebo with respect to pain and disability, with a much greater effect size for pain than disability. When compared with NSAIDs, opioids did not confer a greater benefit with regard to pain and disability. The rate of side effects from opioids is significantly greater than placebo with differences ranging between 2% and 9%. The systematic review of RCTs showed that antidepressants are not more effective than placebo with respect to pain, functional status, or depression. Certain subgroup treatment effects were identified, supporting our hypothesis that chronic LBP should be considered a heterogeneous set of disorders. As such, chronic LBP subgroups should be considered both when making clinical treatment decisions and when designing future research trials. Conclusion. Opioids and NSAIDs are effective for chronic LBP, while antidepressants have no meaningful clinical benefit. Based on the significant rate of side effects with opioids and the lack of convincing superiority over NSAIDs, opioids are not recommended as a treatment for chronic LBP. Attention to subgroups of patients will likely help guide treatment, and will likely help increase the clinical impact of future research. Clinical Recommendations. Recommendation 1: NSAIDs should be considered as a treatment of chronic LBP (Strength: Strong). There is evidence demonstrating favorable effectiveness, but also significant side effects that may have meaningful clinical consequences. Recommendation 2: Opioids may be considered in the treatment of chronic LBP but should be avoided if possible (Strength: Weak). There is evidence demonstrating favorable effectiveness compared to placebo, similar effectiveness compared to NSAIDs, and with significant side effects including decreasing effectiveness related to habituation when used long-term. Recommendation 3: Antidepressants should not be routinely used for the treatment of chronic LBP (Strength: Strong). There is evidence that they are not more effective than placebo with respect to pain, functional status, or depression. Based on the hypothesis that chronic LBP is a symptom reflective of a heterogeneous group of disorders, categorization of certain patient specific subgroups may be helpful in guiding future treatment decision making. It is likely that inclusion of subgroup factors in future RCTs will provide information needed to improve the strength and specificity of future clinical recommendations.

Surgeon perceptions and reported complications in spine surgery.

Study Design. Systematic review. Objective. To define the term “complications” from the spine surgery literature and contrast this with definitions from other federal institutions, to summarize the incidence of adverse events in cervical, thoracic, and lumbar spine surgery, to include the factors that contribute to these events, and to determine the relationship between complications and patient centered outcomes. Summary of Background Data. Efforts to understand and reduce complications in medicine, and spine surgery in particular have been hampered as a result of the lack of a meaningful and universally acceptable definition. The complex field of spine surgery has been a particularly challenging area for the development of a consensus to constructively describe these “undesirable/unanticipated developments arising during or out of the delivery of health care.” Furthermore, an overall understanding of expected complication rates after major spine surgery is lacking. Methods. A systematic review of the English literature was undertaken for articles published between 1990 and December 2008. Electronic and federal databases and reference lists of key articles were searched to identify articles defining complications and reporting rates of spine surgical complications. Two independent reviewers assessed the level of evidence quality using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria and disagreements were resolved by consensus. Results. The definitions for complications in the spine literature and federal agencies are inconsistent and at times conflicting. Mortality rates for cervical spine and lumbar spine surgery are <1%. For thoracic spine surgery, rates range from 0.3% to 7%. Complication rates range from 5% to 19%, 7% to 18%, and 4% to 14% after cervical, thoracic, and lumbar spine surgery, respectively. Findings from a single study indicate that major complications may have an impact on 1-year self-perceived general health. However, minor complications may not. Conclusion. We define a complication as an unintended and undesirable diagnostic or therapeutic event that may impact the patients care. Complications should be recorded and analyzed relative to disease severity, patient comorbidities, and ultimately their effect on patient outcomes. Further work needs to be done to develop a complication risk impact index that has the ability to help us assess and communicate the interaction of patient cormobidities and complication severity on patient centered outcomes.

Does early fracture fixation of thoracolumbar spine fractures decrease morbidity or mortality

Study Design. Systematic Review. Objective. To determine whether early spinal stabilization in thoracolumbar spine trauma decreases morbidity and mortality. Summary of Background Data. The role of early spinal stabilization through surgical means may have a number of benefits. These include reduced morbidity and mortality because of more rapid mobilization afforded by spinal column stabilization and a reduction in the incidence and severity of sepsis and respiratory failure. There are several potential disadvantages of early surgery. The most strongly debated is the potential that the additional physiologic injury may result in an unintended increase in morbidity and mortality caused by worsening of existing injuries, such as with pulmonary or intracranial trauma. This problem may be compounded by increased hemorrhage and resulting hypotension. Operating in the presence of missed or underestimated associated injuries or under less-than-ideal conditions relative to the complexity of the surgery and resources required is also a potential disadvantage. Methods. A systematic review of the English-language literature was undertaken for articles published between January 1990 and December 2008. Electronic databases and reference lists of key articles were searched to identify published studies examining the timing of thoracolumbar fracture fixation. Two independent reviewers assessed the strength of literature using the Grading of Recommendations Assessment, Development, and Evaluation criteria, assessing quality, quantity, and consistency of results. Disagreements were resolved by consensus. Results. A total of 68 articles were initially screened, and 9 ultimately met the predetermined inclusion criteria. These studies demonstrated that early stabilization ofthoracic fractures reduced the mean number of days on a ventilator, the number of days in intensive care unit and in hospital, and reduced respiratory morbidity compared with late stabilization. This effect, other than the length of hospital stay, was not seen with stabilization of lumbar fractures. There is not enough evidence to determine the effect of the timing of stabilization on mortality in thoracolumbar fractures. Conclusion. Ideally, patients with unstable thoracic fractures should undergo early (<72 hours) stabilization of their injury to reduce morbidity and, possibly, mortality.

Predicting the risk of adjacent segment pathology after lumbar fusion: a systematic review.

Study Design. Systematic review. Objective. To perform a systematic review to define the incidence of clinical adjacent segment pathology (CASP) after lumbar fusion surgery and define potential risk factors for the development of CASP. Summary of Background Data. Concerns for the longevity of current arthrodesis constructs and the effects of arthrodesis on adjacent segments have received increasing attention during the past decade. There is a lack of precision regarding the terminology used to describe the pathologies of adjacent segment disease. The term ASP is proposed as an umbrella term to refer to the breadth of clinical and/or radiographical changes at adjacent motion segments that developed subsequent to a previous spinal intervention. Methods. A systematic search was performed in Medline and the Cochrane Collaboration Library for literature published through January 2012. Level of evidence ratings were assigned to each article independently by 2 reviewers. Extracted were the percentage risks of CASP during 5- and 10-year time periods, risk factors, the effect estimates (relative risks and odds ratios), and corresponding confidence intervals reported from each studys multivariate analyses. Forest plots of odds ratios or relative risks with their 95% confidence intervals evaluating patient, disease, and surical risk factors were constructed using the data provided by the individual studies. Results. We identified 162 total citations from our literature search. Of these, 31 full- text articles were evaluated for meeting inclusion criteria. From these 31 studies, 5 studies met inclusion criteria. The mean patient ages ranged from 50 to 64 years. The mean annual incidence of CASP ranged from 0.6% to 3.9%. With respect to patient factors, age more than 60 years was associated with an increased risk of developing CASP. Other factors that may increase the risk of developing CASP are pre-existing facet degeneration, degenerative disc disease, performing a multilevel fusion, stopping a construct at L5, performing a laminectomy adjacent to a fusion, and excessive disc height distraction during posterior interbody fusion. Conclusion. This systematic review was limited to higher-quality studies that evaluated risk factors using multivariate analyses. Identified were key patient, disease, surgical, and radiographical factors that may be considered when counseling and treating patients with degenerative conditions. Further high-quality studies are required before any concrete conclusions can be made about this controversial topic. Consensus StatementsThe risk of developing CASP after lumbar fusion occurs at a mean annual incidence of 0.6% to 3.9%.Strength of Statement: StrongPatients older than 60 years or who have pre-existing facet/disc degeneration may have an increased risk of developing CASP.Strength of Statement: StrongThe risk of developing CASP may be greater after multilevel fusions and fusions adjacent to but not including the L5–S1 level, and may increase when performing a laminectomy adjacent to a fusion.Strength of Statement: Strong

Morbidity and mortality related to odontoid fracture surgery in the elderly population.

Study Design. Systematic analysis. Objective. To determine the morbidity and mortality of surgical treatment of odontoid fractures in the elderly. Summary of Background Data. The prevalence of trauma in the elderly is increasing. There exists no consensus regarding the role of surgical treatment for odontoid fractures in the elderly and there exists significant variability in clinical practice. This variability may be related to a lack of robust information available to clinicians. Importantly, studies that define surgical risk are not available. Methods. A systematic analysis of the English language literature was undertaken for articles published between January 1990 and June 2009. Electronic databases and reference lists of key articles were searched to identify articles examining complications and mortality following odontoid fracture surgery in subjects 65 years of age or older. Two independent reviewers assessed the level of evidence quality using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria, and disagreements were resolved by consensus. Results. The initial literature search yielded 247 articles related to morbidity or mortality following surgery treatment of odontoid fractures in the elderly. After exclusion of articles based on title or abstract information, 48 remained to undergo full text review. Subsequent exclusions yielded 14 articles suited for this analysis. The most commonly reported major complications after odontoid fracture surgery in the elderly include cardiac failure (6.8%), DVT (3.2%), stroke (3.2%), pneumonia (9.9%), respiratory failure (7.7%), liver failure (6.7%), and severe infection (3.2%). Other site specific and minor complications were found to be reported consistently in the literature. The overall mortality rate after surgery is 10.1% (in-hospital, 6.2%; postdischarge, 8.8%). Similar mortality rates were found following anterior surgery (7% in-hospital; 9% overall) and posterior surgery (8% in-hospital; 9% overall); there were no differences in the rate of major airway complications between these groups (anterior: 17%; posterior: 18%). There was, however, a higher rate of site-specific complications, including nonunion, technical failure, and the need for revision surgery, following anterior surgery as compared with posterior surgery. Conclusion. Based on the summary of criteria results, future research evaluating complications following surgery for odontoid fractures in elderly patients is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate currently available in the literature.