Do Cervical Spine Surgery Patients Recall Their Preoperative Status?: A Cohort Study of Recall Bias in Patient-reported Outcomes.

STUDY DESIGN: This is a prospective cohort study. OBJECTIVE: To characterize the accuracy of patient recollection of preoperative symptoms after cervical spine surgery. SUMMARY OF BACKGROUND DATA: Recall bias is a well-known source of systematic error. The accuracy of patient recall after cervical spine surgery remains unknown. METHODS: Consecutive patients undergoing cervical spine surgery for myelopathy or radiculopathy were enrolled. Neck and arm numeric pain scores and Neck Disability Indices were recorded preoperatively. Patients were asked to recall their preoperative status at either short (<1 y) or long-term (≥1 y) follow-up. Actual and recalled scores were compared using paired t tests and relations were quantified using the Pearson correlation coefficients. Multivariable linear regression was used to identify factors impacting recollection. RESULTS: In total, 73 patients with a mean age of 58.2 years were included. Compared with their preoperative scores, patients showed significant improvement in neck pain [mean difference (MD)=-2.9; 95% confidence intervals (CIs), -3.5 to -2.3], arm pain (MD, -3.4; 95% CI, -4.0 to -2.8), and disability (MD, -12.4%; 95% CI, -16.9 to -7.9). Patient recollection of preoperative status was significantly more severe than actual for neck pain (MD, +1.5; 95% CI, 0.8-2.2), arm pain (MD, +2.3; 95% CI, 1.6-3.0), and disability (MD, +5.8%; 95% CI, 2.4-9.2). Moderate correlation between actual and recalled scores with regard to neck (r=0.41), arm (r=0.50) pain, and disability (r=0.67) was seen. This was maintained across age, sex, and time between date of surgery and recollection. Over 30% of patients switched their predominant symptom from neck-to-arm pain or vice versa on recall of their preoperative symptoms. CONCLUSIONS: Relying on patient recollection does not provide an accurate measure of preoperative status after cervical spine surgery. Prospective and not retrospective collection of patient-reported outcomes remain the gold standard to measure and interpret outcomes after cervical spine surgery. Recall bias has the potential to affect patient satisfaction and requires further study.

Does Resection of the Posterior Longitudinal Ligament Impact the Incidence of C5 Palsy After Cervical Corpectomy Procedures?: A Review of 459 Consecutive Cases.

STUDY DESIGN: Retrospective review. OBJECTIVE: To evaluate key risk factors for the development of C5 palsy after cervical corpectomy, including resection of the posterior longitudinal ligament (PLL). SUMMARY OF BACKGROUND DATA: Postoperative C5 palsy is a well-known complication after cervical spine surgery. It is unknown whether resection of the PLL affects the incidence of C5 palsy. METHODS: We performed a retrospective review of 459 consecutive patients undergoing anterior cervical corpectomies over a 15-year period. Medical records were reviewed to gather demographic data, operative details, and the incidence of C5 palsy. We performed regression analyses to identify variables that predicted the development of C5 palsy. RESULTS: Our final analysis included 397 patients (females 51.4%, mean age 55.6 ±â€Š11.6 yrs). Anterior corpectomy alone was performed in 255 (64.2%) patients, and combined anterior and posterior fusion was performed in 142 (35.8%) patients. Twenty-four patients (6.0%) developed C5 nerve palsy. Univariable regression demonstrated age greater than 65 (odds ratio, OR 2.7, 95% confidence interval, CI 1.2 to 6.3), corpectomy of three or more levels (OR 6.3, 95% CI 2.1 to 18.9), presence of ossification of the PLL (OR 4.3, 95% CI 1.6 to 11.7), and complete or partial resection of the PLL (OR 2.6, 95% CI 1.0 to 6.7) predicted development of C5 palsy. Multivariable regression demonstrated that the odds of getting C5 palsy with complete or partial resection of the PLL is 4.0 times (95% CI 1.5 to 10.5) higher compared with patients with an intact PLL. There were no significant differences in C5 palsy rates based on surgical approach (anterior vs. anterior plus posterior), sex, smoking status, or diabetes. CONCLUSION: Age greater than 65 years, corpectomy of three or more levels, presence of ossification of the PLL, and complete or partial resection of the PLL significantly predicted the development of C5 palsy. LEVEL OF EVIDENCE: 4.

Do Lumbar Decompression and Fusion Patients Recall Their Preoperative Status?: A Cohort Study of Recall Bias in Patient-Reported Outcomes.

STUDY DESIGN: Prospective cohort study. OBJECTIVE: To characterize the accuracy of patient recollection of preoperative symptoms after lumbar spine surgery. SUMMARY OF BACKGROUND DATA: Although patient-reported outcomes have become important in the evaluation of spine surgery patients, the accuracy of patient recall remains unknown. METHODS: Patients undergoing lumbar decompression with or without fusion were enrolled. Back and leg Numeric Pain Scores and Oswestry Disability Indices were recorded preoperatively. Patients were asked to recall their preoperative status at a minimum of 1 year after surgery. Actual and recalled scores were compared using paired t tests and relations were quantified using Pearson correlation coefficients. Multivariable linear regression was used to identify factors that affected recollection. RESULTS: Sixty-two patients with a mean age of 66.1 years were included. Compared to their preoperative scores, patients showed significant improvement in back pain (mean difference [MD] = -3.2, 95% CI -4.0 to -2.4), leg pain (MD -3.3, 95% CI -4.3 to -2.2), and disability (MD -25.0%, 95% CI -28.7 to -19.6). Patient recollection of preoperative status was significantly more severe than actual for back pain (MD +2.3, 95% CI 1.5-3.2), leg pain (MD +1.8, 95% CI 0.9-2.7), and disability (MD +9.6%, 95% CI 5.6-14.0). No significant correlation between actual and recalled scores with regards to back (r = 0.18) or leg (r = 0.24) pain and only moderate correlation with disability (r = 0.44) were seen. This was maintained across age, sex, and time between date of surgery and recollection. More than 40% of patients switched their predominant symptom from back pain to leg pain or leg pain to back pain on recall. CONCLUSION: Relying on patient recollection does not provide an accurate measure of preoperative status after lumbar spine surgery. Recall bias indicates the importance of obtaining true baseline scores and patient-reported outcomes prospectively and not retrospectively. LEVEL OF EVIDENCE: 2.

Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 1: introduction and methodology.

Fusion procedures are an accepted and successful management strategy to alleviate pain and/or neurological symptoms associated with degenerative disease of the lumbar spine. In 2005, the first version of the "Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine" was published in the Journal of Neurosurgery: Spine. In an effort to incorporate evidence obtained since the original publication of these guidelines, an expert panel of neurosurgical and orthopedic spine specialists was convened in 2009. Topics reviewed were essentially identical to the original publication. Selected manuscripts from the first iteration of these guidelines as well as relevant publications between 2005 through 2011 were reviewed. Several modifications to the methodology of guideline development were adopted for the current update. In contrast to the 2005 guidelines, a 5-tiered level of evidence strategy was employed, primarily allowing a distinction between lower levels of evidence. The qualitative descriptors (standards/guidelines/options) used in the 2005 recommendations were abandoned and replaced with grades to reflect the strength of medical evidence supporting the recommendation. Recommendations that conflicted with the original publication, if present, were highlighted at the beginning of each chapter. As with the original guideline publication, the intent of this update is to provide a foundation from which an appropriate treatment strategy can be formulated.

Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 2: assessment of functional outcome following lumbar fusion.

Assessment of functional patient-reported outcome following lumbar spinal fusion continues to be essential for comparing the effectiveness of different treatments for patients presenting with degenerative disease of the lumbar spine. When assessing functional outcome in patients being treated with lumbar spinal fusion, a reliable, valid, and responsive outcomes instrument such as the Oswestry Disability Index should be used. The SF-36 and the SF-12 have emerged as dominant measures of general health-related quality of life. Research has established the minimum clinically important difference for major functional outcomes measures, and this should be considered when assessing clinical outcome. The results of recent studies suggest that a patient's pretreatment psychological state is a major independent variable that affects the ability to detect change in functional outcome.

Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 3: assessment of economic outcome.

A comprehensive economic analysis generally involves the calculation of indirect and direct health costs from a societal perspective as opposed to simply reporting costs from a hospital or payer perspective. Hospital charges for a surgical procedure must be converted to cost data when performing a cost-effectiveness analysis. Once cost data has been calculated, quality-adjusted life year data from a surgical treatment are calculated by using a preference-based health-related quality-of-life instrument such as the EQ-5D. A recent cost-utility analysis from a single study has demonstrated the long-term (over an 8-year time period) benefits of circumferential fusions over stand-alone posterolateral fusions. In addition, economic analysis from a single study has found that lumbar fusion for selected patients with low-back pain can be recommended from an economic perspective. Recent economic analysis, from a single study, finds that femoral ring allograft might be more cost-effective compared with a specific titanium cage when performing an anterior lumbar interbody fusion plus posterolateral fusion.

Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 4: radiographic assessment of fusion status.

The ability to identify a successful arthrodesis is an essential element in the management of patients undergoing lumbar fusion procedures. The hypothetical gold standard of intraoperative exploration to identify, under direct observation, a solid arthrodesis is an impractical alternative. Therefore, radiographic assessment remains the most viable instrument to evaluate for a successful arthrodesis. Static radiographs, particularly in the presence of instrumentation, are not recommended. In the absence of spinal instrumentation, lack of motion on flexion-extension radiographs is highly suggestive of a successful fusion; however, motion observed at the treated levels does not necessarily predict pseudarthrosis. The degree of motion on dynamic views that would distinguish between a successful arthrodesis and pseudarthrosis has not been clearly defined. Computed tomography with fine-cut axial images and multiplanar views is recommended and appears to be the most sensitive for assessing fusion following instrumented posterolateral and anterior lumbar interbody fusions. For suspected symptomatic pseudarthrosis, a combination of techniques including static and dynamic radiographs as well as CT images is recommended as an option. Lack of facet fusion is considered to be more suggestive of a pseudarthrosis compared with absence of bridging posterolateral bone. Studies exploring additional noninvasive modalities of fusion assessment have demonstrated either poor potential, such as with (99m)Tc bone scans, or provide insufficient information to formulate a definitive recommendation.

Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 5: correlation between radiographic outcome and function.

In an effort to diminish pain or progressive instability, due to either the pathological process or as a result of surgical decompression, one of the primary goals of a fusion procedure is to achieve a solid arthrodesis. Assuming that pain and disability result from lost mechanical integrity of the spine, the objective of a fusion across an unstable segment is to eliminate pathological motion and improve clinical outcome. However, conclusive evidence of this correlation, between successful fusion and clinical outcome, remains elusive, and thus the necessity of documenting successful arthrodesis through radiographic analysis remains debatable. Although a definitive cause and effect relationship has not been demonstrated, there is moderate evidence that demonstrates a positive association between radiographic presence of fusion and improved clinical outcome. Due to this growing body of literature, it is recommended that strategies intended to enhance the potential for radiographic fusion are considered when performing a lumbar arthrodesis for degenerative spine disease.

Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 6: discography for patient selection.

Identifying the etiology of pain for patients suffering from chronic low-back pain remains problematic. Noninvasive imaging modalities, used in isolation, have not consistently provided sufficient evidence to support performance of a lumbar fusion. Provocative testing has been used as an adjunct in this assessment, either alone or in combination with other modalities, to enhance the diagnostic capabilities when evaluating patients with low-back pain. There have been a limited number of studies investigating this topic since the publication of the original guidelines. Based primarily on retrospective studies, discography, as a stand-alone test, is not recommended to formulate treatment strategies for patients with low-back pain. A single randomized cohort study demonstrated an improved potential of discoblock over discography as a predictor of success following lumbar fusion. It is therefore recommended that discoblock be considered as a diagnostic option. There is a possibility, based on a matched cohort study, that an association exists between progression of degenerative disc disease and the performance of a provocative discogram. It is therefore recommended that patients be counseled regarding this potential development prior to undergoing discography.

Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 8: lumbar fusion for disc herniation and radiculopathy.

Patients suffering from a lumbar herniated disc will typically present with signs and symptoms consistent with radiculopathy. They may also have low-back pain, however, and the source of this pain is less certain, as it may be from the degenerative process that led to the herniation. The surgical alternative of choice remains a lumbar discectomy, but fusions have been performed for both primary and recurrent disc herniations. In the original guidelines, the inclusion of a fusion for routine discectomies was not recommended. This recommendation continues to be supported by more recent evidence. Based on low-level evidence, the incorporation of a lumbar fusion may be considered an option when a herniation is associated with evidence of spinal instability, chronic low-back pain, and/or severe degenerative changes, or if the patient participates in heavy manual labor. For recurrent disc herniations, there is low-level evidence to support the inclusion of lumbar fusion for patients with evidence of instability or chronic low-back pain.

Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 7: lumbar fusion for intractable low-back pain without stenosis or spondylolisthesis.

Establishing an appropriate treatment strategy for patients presenting with low-back pain, in the absence of stenosis or spondylolisthesis, remains a controversial subject. Inherent to this situation is often an inability to adequately identify the source of low-back pain to justify various treatment recommendations, such as lumbar fusion. The current evidence does not identify a single best treatment alternative for these patients. Based on a number of prospective, randomized trials, comparable outcomes, for patients presenting with 1- or 2-level degenerative disc disease, have been demonstrated following either lumbar fusion or a comprehensive rehabilitation program with a cognitive element. Limited access to such comprehensive rehabilitative programs may prove problematic when pursuing this alternative. For patients whose pain is refractory to conservative care, lumbar fusion is recommended. Limitations of these studies preclude the ability to present the most robust recommendation in support of lumbar fusion. A number of lesser-quality studies, primarily case series, also support the use of lumbar fusion in this patient population.

Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 9: lumbar fusion for stenosis with spondylolisthesis.

Patients presenting with stenosis associated with a spondylolisthesis will often describe signs and symptoms consistent with neurogenic claudication, radiculopathy, and/or low-back pain. The primary objective of surgery, when deemed appropriate, is to decompress the neural elements. As a result of the decompression, the inherent instability associated with the spondylolisthesis may progress and lead to further misalignment that results in pain or recurrence of neurological complaints. Under these circumstances, lumbar fusion is considered appropriate to stabilize the spine and prevent delayed deterioration. Since publication of the original guidelines there have been a significant number of studies published that continue to support the utility of lumbar fusion for patients presenting with stenosis and spondylolisthesis. Several recently published trials, including the Spine Patient Outcomes Research Trial, are among the largest prospective randomized investigations of this issue. Despite limitations of study design or execution, these trials have consistently demonstrated superior outcomes when patients undergo surgery, with the majority undergoing some type of lumbar fusion procedure. There is insufficient evidence, however, to recommend a standard approach to achieve a solid arthrodesis. When formulating the most appropriate surgical strategy, it is recommended that an individualized approach be adopted, one that takes into consideration the patient's unique anatomical constraints and desires, as well as surgeon's experience.

Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 10: lumbar fusion for stenosis without spondylolisthesis.

Lumbar stenosis is one of the more common radiographic manifestations of the aging process, leading to narrowing of the spinal canal and foramen. When stenosis is clinically relevant, patients often describe activity-related low-back or lower-extremity pain, known as neurogenic claudication. For those patients who do not improve with conservative care, surgery is considered an appropriate treatment alternative. The primary objective of surgery is to reconstitute the spinal canal. The role of fusion, in the absence of a degenerative deformity, is uncertain. The previous guideline recommended against the inclusion of lumbar fusion in the absence of spinal instability or a likelihood of iatrogenic instability. Since the publication of the original guidelines, numerous studies have demonstrated the role of surgical decompression in this patient population; however, few have investigated the utility of fusion in patients without underlying instability. The majority of studies contain a heterogeneous cohort of subjects, often combining patients with and without spondylolisthesis who received various surgical interventions, limiting fusions to those patients with instability. It is difficult if not impossible, therefore, to formulate valid conclusions regarding the utility of fusion for patients with uncomplicated stenosis. Lower-level evidence exists, however, that does not demonstrate an added benefit of fusion for these patients; therefore, in the absence of deformity or instability, the inclusion of a fusion is not recommended.

Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 12: pedicle screw fixation as an adjunct to posterolateral fusion.

The utilization of pedicle screw fixation as an adjunct to posterolateral lumbar fusion (PLF) has become routine, but demonstration of a definitive benefit remains problematic. The medical evidence indicates that the addition of pedicle screw fixation to PLF increases fusion rates when assessed with dynamic radiographs. More recent evidence, since publication of the 2005 Lumbar Fusion Guidelines, suggests a stronger association between radiographic fusion and clinical outcome, although, even now, no clear correlation has been demonstrated. Although several reports suggest that clinical outcomes are improved with the addition of pedicle screw fixation, there are conflicting findings from similarly classified evidence. Furthermore, the largest contemporary, randomized, controlled study on this topic failed to demonstrate a significant clinical benefit with the use of pedicle screw fixation in patients undergoing PLF for chronic low-back pain. This absence of proof should not, however, be interpreted as proof of absence. Several limitations continue to compromise these investigations. For example, in the majority of studies the sample size is insufficient to detect small increments in clinical outcome that may be observed with pedicle screw fixation. Therefore, no definitive statement regarding the efficacy of pedicle screw fixation as a means to improve functional outcomes in patients undergoing PLF for chronic low-back pain can be made. There appears to be consistent evidence suggesting that pedicle screw fixation increases the costs and complication rate of PLF. High-risk patients, including (but not limited to) patients who smoke, patients who are undergoing revision surgery, or patients who suffer from medical conditions that may compromise fusion potential, may appreciate a greater benefit with supplemental pedicle screw fixation. It is recommended, therefore, that the use of pedicle screw fixation as a supplement to PLF be reserved for those patients in whom there is an increased risk of nonunion when treated with only PLF.

Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 11: interbody techniques for lumbar fusion.

Interbody fusion techniques have been promoted as an adjunct to lumbar fusion procedures in an effort to enhance fusion rates and potentially improve clinical outcome. The medical evidence continues to suggest that interbody techniques are associated with higher fusion rates compared with posterolateral lumbar fusion (PLF) in patients with degenerative spondylolisthesis who demonstrate preoperative instability. There is no conclusive evidence demonstrating improved clinical or radiographic outcomes based on the different interbody fusion techniques. The addition of a PLF when posterior or anterior interbody lumbar fusion is performed remains an option, although due to increased cost and complications, it is not recommended. No substantial clinical benefit has been demonstrated when a PLF is included with an interbody fusion. For lumbar degenerative disc disease without instability, there is moderate evidence that the standalone anterior lumbar interbody fusion (ALIF) has better clinical outcomes than the ALIF plus instrumented, open PLF. With regard to type of interbody spacer used, frozen allograft is associated with lower pseudarthrosis rates compared with freeze-dried allograft; however, this was not associated with a difference in clinical outcome.

Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 13: injection therapies, low-back pain, and lumbar fusion.

The medical literature continues to fail to support the use of lumbar epidural injections for long-term relief of chronic back pain without radiculopathy. There is limited support for the use of lumbar epidural injections for shortterm relief in selected patients with chronic back pain. Lumbar intraarticular facet injections are not recommended for the treatment of chronic lower-back pain. The literature does suggest the use of lumbar medial nerve blocks for short-term relief of facet-mediated chronic lower-back pain without radiculopathy. Lumbar medial nerve ablation is suggested for 3-6 months of relief for chronic lower-back pain without radiculopathy. Diagnostic medial nerve blocks by the double-injection technique with an 80% improvement threshold are an option to predict a favorable response to medial nerve ablation for facet-mediated chronic lower-back pain without radiculopathy, but there is no evidence to support the use of diagnostic medial nerve blocks to predict the outcomes in these same patients with lumbar fusion. There is insufficient evidence to support or refute the use of trigger point injections for chronic lowerback pain without radiculopathy.

Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 14: brace therapy as an adjunct to or substitute for lumbar fusion.

The utilization of orthotic devices for lumbar degenerative disease has been justified from both a prognostic and therapeutic perspective. As a prognostic tool, bracing is applied prior to surgery to determine if immobilization of the spine leads to symptomatic relief and thus justify the performance of a fusion. Since bracing does not eliminate motion, the validity of this assumption is questionable. Only one low-level study has investigated the predictive value of bracing prior to surgery. No correlation between response to bracing and fusion outcome was observed; therefore a trial of preoperative bracing is not recommended. Based on low-level evidence, the use of bracing is not recommended for the prevention of low-back pain in a general working population, since the incidence of low-back pain and impact on productivity were not reduced. However, in laborers with a history of back pain, a positive impact on lost workdays was observed when bracing was applied. Bracing is recommended as an option for treatment of subacute low-back pain, as several higher-level studies have demonstrated an improvement in pain scores and function. The use of bracing following instrumented posterolateral fusion, however, is not recommended, since equivalent outcomes have been demonstrated with or without the application of a brace.

Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 15: electrophysiological monitoring and lumbar fusion.

Intraoperative monitoring (IOM) is commonly used during lumbar fusion surgery for the prevention of nerve root injury. Justification for its use stems from the belief that IOM can prevent nerve root injury during the placement of pedicle screws. A thorough literature review was conducted to determine if the use of IOM could prevent nerve root injury during the placement of instrumentation in lumbar or lumbosacral fusion. There is no evidence to date that IOM can prevent injury to the nerve roots. There is limited evidence that a threshold below 5 mA from direct stimulation of the screw can indicate a medial pedicle breach by the screw. Unfortunately, once a nerve root injury has taken place, changing the direction of the screw does not alter the outcome. The recommendations formulated in the original guideline effort are neither supported nor refuted with the evidence obtained with the current studies.

Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 16: bone graft extenders and substitutes as an adjunct for lumbar fusion.

In an attempt to enhance the potential to achieve a solid arthrodesis and avoid the morbidity of harvesting autologous iliac crest bone (AICB) for a lumbar fusion, numerous alternatives have been investigated. The use of these fusion adjuncts has become routine despite a lack of convincing evidence demonstrating a benefit to justify added costs or potential harm. Potential alternatives to AICB include locally harvested autograft, calcium-phosphate salts, demineralized bone matrix (DBM), and the family of bone morphogenetic proteins (BMPs). In particular, no option has created greater controversy than the BMPs. A significant increase in the number of publications, particularly with respect to the BMPs, has taken place since the release of the original guidelines. Both DBM and the calciumphosphate salts have demonstrated efficacy as a graft extender or as a substitute for AICB when combined with local autograft. The use of recombinant human BMP-2 (rhBMP-2) as a substitute for AICB, when performing an interbody lumbar fusion, is considered an option since similar outcomes have been observed; however, the potential for heterotopic bone formation is a concern. The use of rhBMP-2, when combined with calcium phosphates, as a substitute for AICB, or as an extender, when used with local autograft or AICB, is also considered an option as similar fusion rates and clinical outcomes have been observed. Surgeons electing to use BMPs should be aware of a growing body of literature demonstrating unique complications associated with the use of BMPs.