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Paul Klimo Jr., Clinton J. Thompson, Brian T. Ragel, and Frederick A. Boop

Object

Infection is a serious and costly complication of CSF shunt implantation. Antibiotic-impregnated shunts (AISs) were introduced almost 10 years ago, but reports on their ability to decrease the infection rate have been mixed. The authors conducted a meta-analysis assessing the extent to which AISs reduce the rate of shunt infection compared with standard shunts (SSs). They also examined cost savings to determine the degree to which AISs could decrease infection-related hospital expenses.

Methods

After conducting a comprehensive search of multiple electronic databases to identify studies that evaluated shunt type and used shunt-related infection as the primary outcome, 2 reviewers independently evaluated study quality based on preestablished criteria and extracted data. A random effects meta-analysis of eligible studies was then performed. For studies that demonstrated a positive effect with the AIS, a cost-savings analysis was conducted by calculating the number of implanted shunts needed to prevent a shunt infection, assuming an additional cost of $400 per AIS system and $50,000 to treat a shunt infection.

Results

Thirteen prospective or retrospective controlled cohort studies provided Level III evidence, and 1 prospective randomized study provided Level II evidence. “Shunt infection” was generally uniformly defined among the studies, but the availability and detail of baseline demographic data for the control (SS) and treatment (AIS) groups within each study were variable. There were 390 infections (7.0%) in 5582 procedures in the control group and 120 infections (3.5%) in 3467 operations in the treatment group, yielding a pooled absolute risk reduction (ARR) and relative risk reduction (RRR) of 3.5% and 50%, respectively. The meta-analysis revealed the AIS to be statistically protective in all studies (risk ratio = 0.46, 95% CI 0.33–0.63) and in single-institution studies (risk ratio = 0.38, 95% CI 0.25–0.58). There was some evidence of heterogeneity when studies were analyzed together (p = 0.093), but this heterogeneity was reduced when the studies were analyzed separately as single institution versus multiinstitutional (p > 0.10 for both groups). Seven studies showed the AIS to be statistically protective against infection with an ARR and RRR ranging from 1.7% to 14.2% and 34% to 84%, respectively. The number of shunt operations requiring an AIS to prevent 1 shunt infection ranged from 7 to 59. Assuming 200 shunt cases per year, the annual savings for converting from SSs to AISs ranged from $90,000 to over $1.3 million.

Conclusions

While the authors recognized the inherent limitations in the quality and quantity of data available in the literature, this meta-analysis revealed a significant protective benefit with AIS systems, which translated into substantial hospital savings despite the added cost of an AIS. Using previously developed guidelines on treatment, the authors strongly encourage the use of AISs in all patients with hydrocephalus who require a shunt, particularly those at greatest risk for infection.

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Paul Klimo Jr., Clinton J. Thompson, James Drake, and John R. W. Kestle

Object. Most surgical procedures are associated with a learning curve in which the success rate is lower early in the experience before mistakes have been identified and modifications made to the procedure. Negative results obtained early in a trial's learning curve may be a matter of timing rather than a reflection of the procedure's effectiveness. The recently published results of the Endoscopic Shunt Insertion Trial (ESIT) represent the notion that endoscopically placed shunts were no more likely to survive than conventionally placed shunts. This negative result may be due to inexperience in performing endoscopic surgeries.

Methods. Surgical experience was assessed in two ways. Shunt survival rates were compared between cases treated endoscopically in the 1st and last years of the ESIT. The effect of center volume was evaluated using a Cox proportional hazard model in which the following variables were analyzed: age at registration, the diagnosis of myelomeningocele, head size, method of shunt placement (endoscopic compared with conventional), and center volume.

There was no difference in survival (endurance) of the shunt between patients enrolled in the 1st and last years (log rank = 0.08, p = 0.77). Likewise, no variable in the Cox multivariate model, including center volume, was a significant factor in predicting shunt survival.

Conclusions. The primary result of the ESIT was found to be internally valid. The fact that endoscopic shunt placement did not benefit patients evaluated in the study was not due to early timing of the trial. Any learning curve among the participating surgeons did not adversely affect the results.

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Paul Klimo Jr., Clinton J. Thompson, Lissa C. Baird, and Ann Marie Flannery

Object

The objective of this systematic review and meta-analysis was to answer the following question: Are antibiotic-impregnated shunts (AISs) superior to standard shunts (SSs) at reducing the risk of shunt infection in pediatric patients with hydrocephalus?

Methods

Both the US National Library of Medicine PubMed/MEDLINE database and the Cochrane Database of Systematic Reviews were queried using MeSH headings and key words relevant to AIS use in children. Abstracts were reviewed, after which studies meeting the inclusion criteria were selected. An evidentiary table was assembled summarizing the studies and the quality of their evidence (Classes I–III). A meta-analysis was conducted using a random-effects model to calculate a cumulative estimate of treatment effect using risk ratio (RR). Heterogeneity was assessed using the chi-square and I2 statistics. Based on the quality of the literature and the result of the meta-analysis, a recommendation was rendered (Level I, II, or III).

Results

Six studies, all Class III, met our inclusion criteria. All but one study focused on a retrospective cohort and all but one were conducted at a single institution. Four of the studies failed to demonstrate a lowered infection rate with the use of an AIS. However, when the data from individual studies were pooled together, the infection rate in the AIS group was 5.5% compared with 8.6% in the SS group. Using a random-effects model, the cumulative RR was 0.51 (95% CI 0.29–0.89, p < 0.001), indicating that a shunt infection was 1.96 times more likely in patients who received an SS.

Conclusions

We recommend AIS tubing because of the associated lower risk of shunt infection compared to the use of conventional silicone hardware (quality of evidence: Class III; strength of recommendation: Level III).

Recommendation: Antibiotic-impregnated shunt (AIS) tubing may be associated with a lower risk of shunt infection compared with conventional silicone hardware and thus is an option for children who require placement of a shunt. Strength of Recommendation: Level III, unclear degree of clinical certainty.

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Paul Klimo Jr., Clinton J. Thompson, Brian T. Ragel, and Frederick A. Boop

Object

Neurosurgeons are inundated with vast amounts of new clinical research on a daily basis, making it difficult and time-consuming to keep up with the latest literature. Meta-analysis is an extension of a systematic review that employs statistical techniques to pool the data from the literature in order to calculate a cumulative effect size. This is done to answer a clearly defined a priori question. Despite their increasing popularity in the neurosurgery literature, meta-analyses have not been scrutinized in terms of reporting and methodology.

Methods

The authors performed a literature search using PubMed/MEDLINE to locate all meta-analyses that have been published in the JNS Publishing Group journals (Journal of Neurosurgery, Journal of Neurosurgery: Pediatrics, Journal of Neurosurgery: Spine, and Neurosurgical Focus) or Neurosurgery. Accepted checklists for reporting (PRISMA) and methodology (AMSTAR) were applied to each meta-analysis, and the number of items within each checklist that were satisfactorily fulfilled was recorded. The authors sought to answer 4 specific questions: Are meta-analyses improving 1) with time; 2) when the study met their definition of a meta-analysis; 3) when clinicians collaborated with a potential expert in meta-analysis; and 4) when the meta-analysis was the only focus of the paper?

Results

Seventy-two meta-analyses were published in the JNS Publishing Group journals and Neurosurgery between 1990 and 2012. The number of published meta-analyses has increased dramatically in the last several years. The most common topics were vascular, and most were based on observational studies. Only 11 papers were prepared using an established checklist. The average AMSTAR and PRISMA scores (proportion of items satisfactorily fulfilled divided by the total number of eligible items in the respective instrument) were 31% and 55%, respectively. Major deficiencies were identified, including the lack of a comprehensive search strategy, study selection and data extraction, assessment of heterogeneity, publication bias, and study quality. Almost one-third of the papers did not meet our basic definition of a meta-analysis. The quality of reporting and methodology was better 1) when the study met our definition of a meta-analysis; 2) when one or more of the authors had experience or expertise in conducting a meta-analysis; 3) when the meta-analysis was not conducted alongside an evaluation of the authors' own data; and 4) in more recent studies.

Conclusions

Reporting and methodology of meta-analyses in the neurosurgery literature is excessively variable and overall poor. As these papers are being published with increasing frequency, neurosurgical journals need to adopt a clear definition of a meta-analysis and insist that they be created using checklists for both reporting and methodology. Standardization will ensure high-quality publications.

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Cody L. Nesvick, Clinton J. Thompson, Frederick A. Boop, and Paul Klimo Jr.

Object

Observational studies, such as cohort and case-control studies, are valuable instruments in evidence-based medicine. Case-control studies, in particular, are becoming increasingly popular in the neurosurgical literature due to their low cost and relative ease of execution; however, no one has yet systematically assessed these types of studies for quality in methodology and reporting.

Methods

The authors performed a literature search using PubMed/MEDLINE to identify all studies that explicitly identified themselves as “case-control” and were published in the JNS Publishing Group journals (Journal of Neurosurgery, Journal of Neurosurgery: Pediatrics, Journal of Neurosurgery: Spine, and Neurosurgical Focus) or Neurosurgery. Each paper was evaluated for 22 descriptive variables and then categorized as having either met or missed the basic definition of a case-control study. All studies that evaluated risk factors for a well-defined outcome were considered true case-control studies. The authors sought to identify key features or phrases that were or were not predictive of a true case-control study. Those papers that satisfied the definition were further evaluated using the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist.

Results

The search detected 67 papers that met the inclusion criteria, of which 32 (48%) represented true case-control studies. The frequency of true case-control studies has not changed with time. Use of odds ratios (ORs) and logistic regression (LR) analysis were strong positive predictors of true case-control studies (for odds ratios, OR 15.33 and 95% CI 4.52–51.97; for logistic regression analysis, OR 8.77 and 95% CI 2.69–28.56). Conversely, negative predictors included focus on a procedure/intervention (OR 0.35, 95% CI 0.13–0.998) and use of the word “outcome” in the Results section (OR 0.23, 95% CI 0.082–0.65). After exclusion of nested case-control studies, the negative correlation between focus on a procedure/intervention and true case-control studies was strengthened (OR 0.053, 95% CI 0.0064–0.44). There was a trend toward a negative association between the use of survival analysis or Kaplan-Meier curves and true case-control studies (OR 0.13, 95% CI 0.015–1.12). True case-control studies were no more likely than their counterparts to use a potential study design “expert” (OR 1.50, 95% CI 0.57–3.95). The overall average STROBE score was 72% (range 50–86%). Examples of reporting deficiencies were reporting of bias (28%), missing data (55%), and funding (44%).

Conclusions

The results of this analysis show that the majority of studies in the neurosurgical literature that identify themselves as “case-control” studies are, in fact, labeled incorrectly. Positive and negative predictors were identified. The authors provide several recommendations that may reverse the incorrect and inappropriate use of the term “case-control” and improve the quality of design and reporting of true case-control studies in neurosurgery.

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Paul Klimo Jr., Atmaram S. Pai Panandiker, Clinton J. Thompson, Frederick A. Boop, Ibrahim Qaddoumi, Amar Gajjar, Gregory T. Armstrong, David W. Ellison, Larry E. Kun, Robert J. Ogg, and Robert A. Sanford

Object

Whereas diffuse intrinsic pontine gliomas generally have a short symptom duration and more cranial nerve involvement, focal brainstem gliomas are commonly low grade, with fewer cranial neuropathies. Although these phenotypic distinctions are not absolute predictors of outcome, they do demonstrate correlation in most cases. Because there is a limited literature on focal brainstem gliomas in pediatric patients, the objective of this paper was to report the management and outcome of these tumors.

Methods

The authors reviewed the records of all children diagnosed with radiographically confirmed low-grade focal brainstem gliomas from 1986 to 2010. Each patient underwent biopsy or resection for tissue diagnosis. Event-free survival (EFS) and overall survival were evaluated. Univariate analysis was conducted to identify demographic and treatment variables that may affect EFS.

Results

Fifty-two patients (20 girls, 32 boys) with follow-up data were identified. Median follow-up was 10.0 years, and the median age at diagnosis was 6.5 years (range 1–17 years). The tumor locations were midbrain (n = 22, 42%), pons (n = 15, 29%), and medulla (n = 15, 29%). Surgical extirpation was the primary treatment in 25 patients (48%). The 5- and 10-year EFS and overall survival were 59%/98% and 52%/90%, respectively. An event or treatment failure occurred in 24 patients (46%), including 5 deaths. Median time to treatment failure was 3.4 years. Disease progression in the other 19 patients transpired within 25.1 months of diagnosis. Thirteen of these patients received radiation, including 11 within 2 months of primary treatment failure. Although children with intrinsic tumors had slightly better EFS at 5 years compared with those with exophytic tumors (p = 0.054), this difference was not significant at 10 years (p = 0.147). No other variables were predictive of EFS.

Conclusions

Surgery suffices in many children with low-grade focal brainstem gliomas. Radiation treatment is often reserved for disease progression but offers comparable disease control following biopsy. In the authors' experience, combining an assessment of clinical course, imaging, and tumor biopsy yields a reasonable model for managing children with focal brainstem tumors.

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Paul Klimo Jr., Mark Van Poppel, Clinton J. Thompson, Lissa C. Baird, Ann-Christine Duhaime, and Ann Marie Flannery

Object

The objective of this systematic review and meta-analysis was twofold: to answer the question “What is the evidence for the effectiveness of prophylactic intravenous antibiotics for infection prevention in shunt surgery?” and to make treatment recommendations based on the available evidence.

Methods

The US National Library of Medicine PubMed/MEDLINE database and the Cochrane Database of Systematic Reviews were queried using MeSH headings and key words relevant to prophylactic antibiotic use in children undergoing a shunt operation. Abstracts were reviewed to identify which studies met the inclusion criteria. An evidentiary table was assembled summarizing the studies and the quality of evidence (Classes I-III). A meta-analysis was conducted using a random-effects model to calculate a cumulative estimate of treatment effect using risk ratio (RR). Heterogeneity was assessed using chi-square and I2 statistics. A sensitivity analysis was also conducted. Based on the quality of the literature and the result of the meta-analysis, a recommendation was rendered (Level I, II, or III).

Results

Nine studies (4 Class I, 3 Class II, and 2 Class III) met our inclusion criteria. Of 7 randomized controlled trials (RCTs), 3 were downgraded from Class I to Class II because of significant quality issues, and all RCTs were potentially underpowered. In only 2 Class in retrospective cohort studies were preoperative antibiotic agents found to be protective against shunt infection. When data from the individual studies were pooled together, the infection rate in the prophylactic antibiotics group was 5.9% compared with 10.7% in the control group. Using a random-effects model, the cumulative RR was 0.55 (95% CI 0.38–0.81), indicating a protective benefit of prophylactic preoperative intravenous antibiotics. A sensitivity analysis of RCTs only (n = 7) also demonstrated a statistical benefit, but an analysis of higher-quality RCTs only (n = 4) did not.

Conclusions

Within the limits of this systematic review and meta-analysis, administration of preoperative antibiotic agents for shunt surgery in children was found to lower the infection risk (quality of evidence: Class II; strength of recommendation, Level II).

Recommendation

The use of preoperative antibiotic agents can be recommended to prevent shunt infection in patients with hydrocephalus. It was only by combining the results of the various underpowered studies (meta-analysis) that the use of preoperative antibiotics for shunt surgery in children was shown to lower the risk of shunt infection. Strength of Recommendation: Level II, moderate degree of clinical certainty.

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Nickalus R. Khan, Clinton J. Thompson, Michael DeCuypere, Jonathan M. Angotti, Erick Kalobwe, Michael S. Muhlbauer, Francis X. Camillo, and Paul Klimo Jr.

Object

Surgical site infection (SSI) is a serious and costly complication of spinal surgery. There have been several conflicting reports on the use of intrawound vancomycin powder in decreasing SSI in spine surgery. The purpose of this study is to answer the question: “Does intrawound vancomycin powder reduce the rate of SSIs in spine surgery?”

Methods

A comprehensive search of multiple electronic databases and bibliographies was conducted to identify clinical studies that evaluated the rates of SSI with and without the use of intrawound vancomycin powder in spine surgery. Independent reviewers extracted data and graded the quality of each paper that met inclusion criteria. A random effects meta-analysis was then performed.

Results

The search identified 9 retrospective cohort studies (Level III evidence) and 1 randomized controlled trial (Level II evidence). There were 2574 cases and 106 infections in the control group (4.1%) and 2518 cases and 33 infections (1.3%) in the treatment group, yielding a pooled absolute risk reduction and relative risk reduction of 2.8% and 68%, respectively. The meta-analysis revealed the use of vancomycin powder to be protective in preventing SSI (relative risk = 0.34, 95% confidence interval 0.17–0.66, p = 0.021). The number needed to treat to prevent 1 SSI was 36. A subgroup analysis found that patients who had implants had a reduced risk of SSI with vancomycin powder (p = 0.023), compared with those who had noninstrumented spinal operations (p = 0.226).

Conclusions

This meta-analysis suggests that the use of vancomycin powder may be protective against SSI in open spinal surgery; however, the exact population in which it should be used is not clear. This benefit may be most appreciated in higher-risk populations or in facilities with a high baseline rate of infection.

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Paul Klimo Jr., Garrett T. Venable, Nickalus R. Khan, Douglas R. Taylor, Brandon A. Shepherd, Clinton J. Thompson, and Nathan R. Selden

Object

The application of bibliometric techniques to academic neurosurgery has been the focus of several recent publications. The authors provide here a detailed analysis of all active pediatric neurosurgeons in North America and their respective departments.

Methods

Using Scopus and Google Scholar, a bibliometric profile for every known active pediatric neurosurgeon in North America was created using the following citation metrics: h-, contemporary h-, g-, and e-indices and the m-quotient. Various subgroups were compared. Departmental productivity from 2008 through 2013 was measured, and departments were ranked on the basis of cumulative h- and e-indices and the total number of publications and citations. Lorenz curves were created, and Gini coefficients were calculated for all departments with 4 or more members.

Results

Three hundred twelve pediatric neurosurgeons (260 male, 52 female) were included for analysis. For the entire group, the median h-index, m-quotient, contemporary h-, g-, and e-indices, and the corrected g- and e-indices were 10, 0.59, 7, 18, 17, 1.14, and 1.01, respectively; the range for each index varied widely. Academic pediatric neurosurgeons associated with fellowship programs (compared with unassociated neurosurgeons), academic practitioners (compared with private practitioners), and men (compared with women) had superior measurements. There was no significant difference between American and Canadian pediatric neurosurgeons. The mean Gini coefficient for publications was 0.45 (range 0.18–0.70) and for citations was 0.53 (range 0.25–0.80).

Conclusions

This study represents the most exhaustive evaluation of academic productivity for pediatric neurosurgeons in North America to date. These results should serve as benchmarks for future studies.

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Joseph H. McAbee, Joseph Modica, Clinton J. Thompson, Alberto Broniscer, Brent Orr, Asim F. Choudhri, Frederick A. Boop, and Paul Klimo Jr.

OBJECT

Cervicomedullary tumors (CMTs) represent a heterogeneous group of intrinsic neoplasms that are typically low grade and generally carry a good prognosis. This single-institution study was undertaken to document the outcomes and current treatment philosophy for these challenging neoplasms.

METHODS

The charts of all pediatric patients with CMTs who received treatment at St. Jude Children’s Research Hospital between January 1988 and May 2013 were retrospectively reviewed. Demographic, surgical, clinical, radiological, pathological, and survival data were collected. Treatment-free survival and overall survival were estimated, and predictors of recurrence were analyzed.

RESULTS

Thirty-one children (16 boys, 15 girls) with at least 12 months of follow-up data were identified. The median age at diagnosis was 6 years (range 7 months-17 years) and the median follow-up was 4.3 years. Low-grade tumors (Grade I or II) were present in 26 (84%) patients. Thirty patients underwent either a biopsy alone or resection, with the majority of patients undergoing biopsy only (n = 12, 39%) or subtotal resection (n = 14, 45%). Only 4 patients were treated solely with resection; 21 patients received radiotherapy alone or in combination with other treatments. Recurrent tumor developed in 14 children (45%) and 4 died as a result of their malignancy. A high-grade pathological type was the only independent variable that predicted recurrence. The 5- and 10-year treatment-free survival estimates are 64.7% and 45.3%, respectively. The 5- and 10-year overall survival estimate is 86.7%.

CONCLUSIONS

Children with CMTs typically have low-grade neoplasms and consequently long-term survival, but high risk of recurrence. Therapy should be directed at achieving local tumor control while preserving and even restoring neurological function.