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.
Abstract Background context Spinal epidural abscess (SEA) is a rare, serious and increasingly frequent diagnosis. Ideal management (medical vs. surgical) remains controversial. Purpose The purpose of ...this study is to assess the impact of risk factors, organisms, location and extent of SEA on neurologic outcome after medical management or surgery in combination with medical management. Study design Retrospective electronic medical record (EMR) review. Patient sample We included 128 consecutive, spontaneous SEA from a single tertiary medical center, from January 2005 to September 11. There were 79 male and 49 female with a mean age of 52.9 years (range, 22–83). Outcome measures Patient demographics, presenting complaints, radiographic features, pre/post-treatment neurologic status (ASIA motor score MS 0–100), treatment (medical vs. surgical) and clinical follow-up were recorded. Neurologic status was determined before treatment and at last available clinical encounter. Imaging studies reviewed location/extent of pathology. Methods Inclusion criteria were a diagnosis of a bacterial SEA based on radiographs and/or intraoperative findings, age greater than 18 years, and adequate EMR. Exclusion criteria were postinterventional infections, Pott's disease, isolated discitis/osteomyelitis, treatment initiated at an outside facility, and imaging suggestive of a SEA but negative intraoperative findings/cultures. Results The mean follow-up was 241 days. The presenting chief complaint was site-specific pain (100%), subjective fevers (50%), and weakness (47%). In this cohort, 54.7% had lumbar, 39.1% thoracic, 35.9% cervical, and 23.4% sacral involvement spanning an average of 3.85 disc levels. There were 36% ventral, 41% dorsal, and 23% circumferential infections. Risk factors included a history of IV drug abuse (39.1%), diabetes mellitus (21.9%), and no risk factors (22.7%). Pathogens were methicillin-sensitive Staphylococcus aureus (40%) and methicillin-resistance S aureus (30%). Location, SEA extent, and pathogen did not impact MS recovery. Fifty-one patients were treated with antibiotics alone (group 1), 77 with surgery and antibiotics (group 2). Within group 1, 21 patients (41%) failed medical management (progressive MS loss or worsening pain) requiring delayed surgery (group 3). Irrespective of treatment, MS improved by 3.37 points. Thirty patients had successful medical management (MS: pretreatment, 96.5; post-treatment, 96.8). Twenty-one patients failed medical therapy (41%; MS: pretreatment, 99.86, decreasing to 76.2 mean change, −23.67 points, postoperative improvement to 85.0; net deterioration, −14.86 points). This is significantly worse than the mean improvement of immediate surgery (group 2; MS: pretreatment, 80.32; post-treatment, 89.84; recovery, 9.52 points). Diabetes mellitus, C-reactive protein greater than 115, white blood count greater than 12.5, and positive blood cultures predict medical failure: None of four parameters, 8.3% failure; one parameter, 35.4% failure; two parameters, 40.2% failure; and three or more parameters, 76.9% failure. Conclusion Early surgery improves neurologic outcomes compared with surgical treatment delayed by a trial of medical management. More than 41% of patients treated medically failed management and required surgical decompression. Diabetes, C-reactive protein greater than 115, white blood count greater than 12.5, and bacteremia predict failure of medical management. If a SEA is to be treated medically, great caution and vigilance must be maintained. Otherwise, early surgical decompression, irrigation, and debridement should be the mainstay of treatment.
Systematic review.
To determine the definition and incidence of significant hemorrhage in adult spine fusion surgery, and to assess whether measures to decrease hemorrhage are effective.
Significant ...hemorrhage and associated comorbidities in spine fusion surgery have not yet been clearly identified. Several preoperative and intraoperative techniques are currently available to reduce blood loss and transfusion requirements such as cell saver (CS), recombinant factor VIIa, and perioperative antifibrinolytic agents, such as aprotinin, tranexamic acid, and epsilon-aminocaproic acid. Their effectiveness and safety in spine surgery is uncertain.
A systematic review of the English-language literature was undertaken for articles published between January 1990 and April 2009. Electronic databases and reference lists of key articles were searched to identify published studies examining blood loss in major spine surgery. Two independent reviewers assessed the quality of the literature using the Grading of Recommendations Assessment, Development, and Evaluation criteria. Disagreements were resolved by consensus.
A total of 90 articles were initially screened, and 17 ultimately met the predetermined inclusion criteria. No studies were found that attempted to define significant hemorrhage in adult spine surgery. We found that there is a high level of evidence that antifibrinolytic agents reduce blood loss and the need of transfusion in adult spine surgery; however, the safety profile of these agents is unclear. There is very low evidence to support the use of CS, recombinant factor VIIa, activated growth factor platelet gel, or normovolemic hemodilution as a method to prevent massive hemorrhage in spine fusion surgery.
There is no consensus definition of significant hemorrhage in adult spine fusion surgery. However, definition in the anesthesiology literature of massive blood loss is somewhat arbitrary but is commonly accepted to entail loss of 1 volume of the patient's total blood (60 mL/kg in adults) in <24 hours. On the basis of the current literature, there is little support for routine use of CS during elective spinal surgery. Concerns related to the use of aprotinin were such that our panel of experts unanimously recommended against its use in spine surgery on the basis of the reports of increased complications. With respect to the antifibrinolytics of the lysine analog class (tranexamic acid and aminocaproic acid), on the basis of the available efficacy and safety data, we recommend that they be considered as possible agents to help reduce major hemorrhage in adult spine surgery.
OBJECTIVEThe purpose of this study was to compare total cost and length of stay (LOS) between spine surgery patients enrolled in an enhanced perioperative care (EPOC) pathway and patients receiving ...traditional perioperative care (TRDC).METHODSAll spine surgery candidates were screened for inclusion in the EPOC pathway. This cohort was compared to a retrospective cohort of patients who received TRDC and a concurrent group of patients who met inclusion criteria but did not receive the EPOC (no pathway care NOPC group). Direct and indirect costs as well as hospital and intensive care LOSs were analyzed between the 3 groups.RESULTSTotal costs after pathway implementation decreased by $19,344 in EPOC patients compared to a historical cohort of patients who received TRDC and $5889 in a concurrent cohort of patients who did not receive EPOC (NOPC group). Hospital and intensive care LOS were significantly lower in EPOC patients compared to TRDC and NOPC patients.CONCLUSIONSThe implementation of a multimodal EPOC pathway decreased LOS and cost in major elective spine surgeries.
Abstract Background context The ideal management of cervical spine epidural abscess (CSEA), medical versus surgical, is controversial. The medical failure rate and neurologic consequences of delayed ...surgery are not known. Purpose The purpose of this study is to assess the neurologic outcome of patients with CSEA managed medically or with early surgical intervention and to identify the risk factors for medical failure and the consequences of delayed surgery. Study design/setting Retrospective electronic medical record (EMR) review. Patient sample Sixty-two patients with spontaneous CSEA, confirmed with advanced imaging, from a single tertiary medical center from January 5 to September 11. Outcome measures Patient data were collected from the EMR with motor scores (MS) (American Spinal Injury Association 0–100) recorded pre/posttreatment. Three treatment groups emerged: medical without surgery, early surgery, and those initially managed medically but failed requiring delayed surgery. Methods Inclusion criteria: spontaneous CSEA based on imaging and intraoperative findings when available, age >18 years, and adequate EMR documentation of the medical decision-making process. Exclusion criteria: postoperative infections, Pott disease, isolated discitis/osteomyelitis, and patients with imaging findings suggestive of CSEA but negative intraoperative findings and cultures. Results Of the 62 patients included, 6 were successfully managed medically (Group 1) with MS increase of 2.3 points (standard deviation SD 4.4). Thirty-eight patients were treated with early surgery (Group 2) (average time to operating room 24.4 hours SD 19.2 with average MS increase 11.89 points SD 19.5). Eighteen failed medical management (Group 3) requiring delayed surgery (time to OR 7.02 days SD 5.33) with a net MS drop of 15.89 (SD 24.9). The medical failure rate was 75%. MS change between early and delayed surgery was significant (p<.001) favoring early surgery. Risk factors and laboratory data did not predict medical failure or posttreatment MS because of the high number of medical failures when abscess involves the cervical epidural space. Conclusions Early surgery results in improved posttreatment MS compared with medical failure and delayed surgery. In our patients, the failure rate of medical management was high, 75%. Based on our results, we recommend early surgical decompression for all CSEA.
STUDY DESIGN.The Spine End Results Registry (2003–2004) is a registry of prospectively collected data of all patients undergoing spinal surgery at the University of Washington Medical Center and ...Harborview Medical Center. Insurance data were prospectively collected and used in multivariate analysis to determine risk of perioperative complications.
OBJECTIVE.Given the negative financial impact of surgical site infections (SSIs) and the higher overall complication rates of patients with a Medicaid payer status, we hypothesized that a Medicaid payer status would have a significantly higher SSI rate.
SUMMARY OF BACKGROUND DATA.The medical literature demonstrates lesser outcomes and increased complication rates in patients who have public insurance than those who have private insurance. No one has shown that patients with a Medicaid payer status compared with Medicare and privately insured patients have a significantly increased SSI rate for spine surgery.
METHODS.The prospectively collected Spine End Results Registry provided data for analysis. SSI was defined as treatment requiring operative debridement. Demographic, social, medical, and the surgical severity index risk factors were assessed against the exposure of payer status for the surgical procedure.
RESULTS.The population included Medicare (N = 354), Medicaid (N = 334), the Veteransʼ Administration (N = 39), private insurers (N = 603), and self-pay (N = 42). Those patients whose insurer was Medicaid had a 2.06 odds (95% confidence interval1.19–3.58, P = 0.01) of having a SSI compared with the privately insured.
CONCLUSION.The study highlights the increased cost of spine surgical procedures for patients with a Medicaid payer status with the passage of the Patient Protection and Affordable Care Act of 2010. The Patient Protection and Affordable Care Act of 2010 provisions could cause a reduction in reimbursement to the hospital for taking care of patients with Medicaid insurance due to their higher complication rates and higher costs. This very issue could inadvertently lead to access limitations.Level of Evidence3
Abstract Background context Incidental durotomy during spine surgery is a common occurrence, with a reported incidence ranging from 3% to 16%. Risk factors identified by prior studies include age, ...type of procedure, revision surgery, ossification of the posterior longitudinal ligament, gender, osteoporosis, and arthritis. However, these studies are largely univariate analyses using retrospectively recorded data. Purpose To identify and quantify statistically significant risk factors for inadvertent durotomy during spine surgery. Study design Multivariate analysis of prospectively collected registry data. The University of Washington Spine End Results Registry 2003 and 2004 is a compilation of prospectively collected detailed data on 1,745 patients who underwent spine surgery during 2003 to 2004. Patient sample One thousand seven hundred forty-five patients underwent spine surgery from 2003 to 2004 at our two institutions. Outcome measures Cardiac, pulmonary, gastrointestinal, neurologic, renal, and urologic complications defined a priori data collection. Methods Using these data, univariate and multivariate statistical analyses were performed to identify and quantify risk factors for incidental durotomy during spine surgery. Relative risk (RR) values with valid confidence intervals and p values were determined using these data. Results Our multivariate analysis demonstrated that age, lumbar surgery, revision surgery, and elevated surgical invasiveness are significant risk factors for unintended durotomy. Of these, revision surgery was the strongest risk factor for dural tear (RR, 2.21). Diabetes was a significant risk factor in the univariate analysis but not in the multivariate analysis. Conclusions Revision surgery, age, lumbar surgery, degenerative disease, and elevated surgical invasiveness are significant risk factors for unintended durotomy during spine surgery. These data can be useful to surgeons and patients when considering surgical treatment.
Ankylosing spinal disorder (ASD) patients are at a greater risk for spinal fractures due to osteoporosis and rigidity of the spinal column. These fractures are associated with a high risk of ...neurologic compromise resulting from delayed or missed diagnoses. Although computed tomography (CT) is usually the initial imaging modality, magnetic resonance imaging (MRI) has been proposed as mandatory to help identify spinal injuries in ASD patients with unexplained neck or back pain or known injuries to help identify noncontiguous fractures. However, some studies have also shown that neurological injury can result from the required patient transfer and positioning for an MRI.
The purpose of our study was to assess the frequency with which an MRI identified an injury not previously identified with CT, and whether this affected the treatment and outcome of the patient. Secondarily, we attempted to identify clinical or CT findings that may render an MRI particularly useful.
Retrospective review.
Patients with ASD who sustained acute spine fractures from 2005 to 2015.
Acute fractures identified by CT scan and MRI upon admission; neurologic status upon admission and discharge, mode of injury, type of fracture, and final intervention before and after MRI assessment.
A total of 124 patients with a diagnosis of diffuse idiopathic skeletal hyperostosis (DISH) or ankylosing spondylitis (AS) were identified by searching the radiology database of a level I trauma center with diagnosis keywords. Final radiology reports were assessed to determine presence and type of fracture(s) from CT. MRI report was then reviewed to assess if additional fractures or injuries were identified beyond that already known from the CT. Neurologic status upon admission and discharge, mode of injury, type of fracture, and final intervention were determined by inpatient notes and/or operative reports. No source funding or conflict of interest was present pertaining to this study.
In the designated time frame, 124 ASD patients with injuries of the spine were identified who had obtained both a baseline CT and MRI. Six patients (4.8%) had additional injuries on MRI that had not been identified with CT. Four of these six patients had a change in treatment plan (three operative and one nonoperative) based on subsequent MRI findings. These included a (1) C4–5 hyperextension injury, (2) C6–7 hyperextension injury, (3) C7 bony fracture with C5–T4 epidural hematoma, and (4) C5–C6 hyperextension injury treated in a brace. Two of the six patients that had additional injuries identified on MRI had no change in their treatment plan. One patient had an additional lumbar extension injury identified above a previously diagnosed injury on CT, which was managed with a Thoracolumbosacral Orthosis (TLSO) according to the original plan. One patient died who had a known odontoid fracture and a suspected C6–7 hyperextension injury, and was identified on MRI as also having a C3–C4 hyperextension injury and a C2 spinal cord transection.
In this study, 3.2% (4/124) of patients with ASD who presented to a level I trauma center with an acute spine injury identified with CT required a change in their treatment plan based on subsequent MRI findings. Only one fracture was missed on CT imaging, with the other missed injuries all being either disco-ligamentous hyperextension injuries through mobile discs or intracanal pathology. Our recommendation is that the routine use of MRI be limited to patients with nonankylosed levels in which a disco-ligamentous injury may have occurred, and in patients with neurological deficits that require investigation of the spinal canal to assess for causes of neurological injury.
Abstract Background Context In contrast to the majority of outcome data, many consider C1 fractures to be benign injuries and so have advocated for conservative management, except in the case of ...concomitant transverse atlantal ligament (TAL) injury where C1–C2 or occiput–C2 fusions are recommended. Purpose Our goal was to evaluate a series of unstable C1 fractures treated with C1 open reduction and internal fixation (ORIF) to assess clinical and radiographic outcomes by determining the success of reduction and pain relief. Study Design/Setting This is a retrospective cohort review. Patient Sample The sample includes adult patients with unstable C1 fractures treated with open reduction and primary internal fixation. Outcome Measures Primary outcome measures included visual analog pain scale (VAS), radiographic reduction (lateral mass displacement), maintenance of reduction, C1–C2 instability, and complications. Methods A retrospective review of all patients with C1 fractures between September 2002 and September 2013 identified 12 consecutive patients from a level I trauma center who were treated with primary internal fixation without fusion. Electronic medical records and preoperative and postoperative radiographs were reviewed. The surgical technique consisted of a posterior cervical approach to the C1 arch and open reduction using bilateral C1 lateral mass screws connected transversely with a rod. Pre- and postoperative computed tomography scans were used to assess reduction. Long-term follow-up flexion and extension radiographs were used to assess C1–C2 stability. The authors did not receive relevant funding in relation to this research. Results Twelve patients underwent C1 ORIF, with a mean age of 43 (9 males and 3 females) and a mean follow-up of 17 months. Transverse atlantal ligament was found to be disrupted with type I or type II injury in 11 of the 12 patients: 5 type I and 6 type II. Preoperative lateral mass displacement averaged 7.1 mm, with postoperative displacement after reduction averaging 2.4 mm (p-value <.001). The VAS score averaged 0.7 at latest follow-up. No patients went on to develop C1–C2 instability on final flexion-extension films. No patients had a complication that resulted in neurologic deficit or vascular injury associated with the procedure. No patients were found to have late sequelae of malunion or loss of reduction. Two surgically related complications occurred, namely one patient with errant screw requiring return to the operating room (OR) and one with arthrosis of the occipital–C1 joint. Conclusions Although a small series, early evidence suggests that patients with unstable C1 ring fractures can be successfully managed with primary ORIF. Open reduction and internal fixation results in a stable construct that maintains reduction, results in excellent pain control, and does not lead to C1–C2 instability. In our series, we have not observed the presence of TAL injury to adversely affect outcomes, and thus do not believe it is a contraindication to ORIF. Comparative studies comparing internal fixation with non-operative, C1–C2, or occiput–C2 fusions would yield more insight into optimal treatment options for these fractures.
Thoracic costotransversectomies are among the most invasive spinal procedures performed and are associated with unanticipated medical and surgical complications. Few studies have specifically ...assessed medical and surgical complications after a thoracic corpectomy via a costotransversectomy approach (TCT) or compared complications between different diagnoses. The purpose of this study was to describe the differences in operative characteristics and rates of 90-day surgical and medical complications in patients undergoing TCTs based on underlying diagnosis.
A retrospective chart review of 123 consecutive patients who underwent TCTs at a single academic referral center over a 10-year period was conducted. Surgical indication, corpectomy levels, intraoperative dural tears, pleural injuries, neurological injuries, 90-day mortality, 90-day reoperations, and hospital-based medical complications were evaluated.
One hundred twenty-three patients underwent a TCT, including 35 for infection, 42 for malignancy, 23 for trauma, and 23 for deformity. Fifty-nine patients (48.0%) had at least one medical or 90-day operative complication, with 22 patients (17.9%) having two or more complications. Patients with a diagnosis of infection were more likely to undergo two-level corpectomies (80% vs 26.1%, p < 0.0005). Patients with a diagnosis of malignancy had significantly higher 90-day mortality (19.0% vs 4.9%, p = 0.022) and were more likely to undergo three-level corpectomies (9.5% vs 3.7%, p = 0.002) and upper thoracic (T1-4) corpectomies (37.9% vs 12.4%, p = 0.001), and sustain a pleural injury (14.3% vs 2.5%, p = 0.019). Ninety-day reoperation rates (p = 0.970), postoperative ventilator days (p = 0.224), intensive care unit stays (p = 0.350), hospital lengths of stay (p = 0.094), neurological injuries (p = 0.338), and dural tears (p = 0.794) did not significantly vary between the different groups.
Nearly half of the patients undergoing a TCT will experience an unanticipated short-term complication related to the procedure. Short-term complications may vary with the underlying patient diagnosis.
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