The cost-effectiveness of metformin in the US diabetes prevention program trial: Simple interpretations need not apply.

Based on previously published US Diabetes Prevention Program (DPP) cost-effectiveness analyses (CEAs) metformin continues to be promoted as "cost-effective." We review the DPP within-trial CEA to assess this claim. Treatment alternatives included placebo (plus standard lifestyle advice), branded metformin and individual lifestyle modification. We added generic metformin as an alternative. Original published CEA data were taken as given and re-analyzed according to accepted principles for calculating incremental cost-effectiveness ratios (ICERs) in the economic evaluation field. With more than two treatments as in the DPP, these require attention to the rankings of interventions according to cost or effect prior to stipulating appropriate ICERs to calculate. With proper ICERs neither branded nor generic metformin was cost-effective, regardless of the value assumed for the willingness to pay for the quality-adjusted life year outcome assessed. Metformin alternatives were technically inefficient compared to placebo or the lifestyle modification alternative. Net loss calculations indicated substantial costs/health losses to using metformin instead of the optimal lifestyle alternative in response to metformin having been inaccurately labelled "cost-effective" in the original CEA. That CEA and subsequent analyses and citations of such analyses continue to claim that both metformin and lifestyle modification are cost-effective in diabetes prevention based on DPP data. Using metformin implies substantial costs and health losses compared to the cost-effective lifestyle modification. It may be that metformin has a role in cost-effective diabetes prevention, but this has yet to be shown based on DPP data.

FDA-approved machine learning algorithms in neuroradiology: A systematic review of the current evidence for approval.

Over the past decade, machine learning (ML) and artificial intelligence (AI) have become increasingly prevalent in the medical field. In the United States, the Food and Drug Administration (FDA) is responsible for regulating AI algorithms as "medical devices" to ensure patient safety. However, recent work has shown that the FDA approval process may be deficient. In this study, we evaluate the evidence supporting FDA-approved neuroalgorithms, the subset of machine learning algorithms with applications in the central nervous system (CNS), through a systematic review of the primary literature. Articles covering the 53 FDA-approved algorithms with applications in the CNS published in PubMed, EMBASE, Google Scholar and Scopus between database inception and January 25, 2022 were queried. Initial searches identified 1505 studies, of which 92 articles met the criteria for extraction and inclusion. Studies were identified for 26 of the 53 neuroalgorithms, of which 10 algorithms had only a single peer-reviewed publication. Performance metrics were available for 15 algorithms, external validation studies were available for 24 algorithms, and studies exploring the use of algorithms in clinical practice were available for 7 algorithms. Papers studying the clinical utility of these algorithms focused on three domains: workflow efficiency, cost savings, and clinical outcomes. Our analysis suggests that there is a meaningful gap between the FDA approval of machine learning algorithms and their clinical utilization. There appears to be room for process improvement by implementation of the following recommendations: the provision of compelling evidence that algorithms perform as intended, mandating minimum sample sizes, reporting of a predefined set of performance metrics for all algorithms and clinical application of algorithms prior to widespread use. This work will serve as a baseline for future research into the ideal regulatory framework for AI applications worldwide.

The optimal treatment of type II and III odontoid fractures in the elderly: an updated meta-analysis.

PURPOSE: Odontoid fractures are the most common cervical spine fractures in the elderly, with a controversial optimal treatment. The objective of this review was to compare the outcome of surgical and conservative treatments in elderly (≥ 65 years), by updating a systematic review published by the authors in 2013. METHODS: A comprehensive search was conducted in seven databases. Clinical outcome was the primary outcome. Fracture union- and stability were secondary outcomes. Pooled point estimates and their respective 95% confidence intervals (CIs) were derived using the random-effects model. A random-effects multivariable meta-regression model was used to correct for baseline co-variates when sufficiently reported. RESULTS: Forty-one studies met the inclusion criteria, of which forty were case series and one a cohort study. No clinical differences in outcomes including the Neck Disability Index (NDI, 700 patients), Visual Analogue Scale pain (VAS, 180 patients), and Smiley-Webster Scale (SWS, 231 patients) scores were identified between surgical and conservative treatments. However, fracture union was higher in surgically treated patients (pooled incidence 72.7%, 95% CI 66.1%, 78.5%, 31 studies, 988 patients) than in conservatively treated patients (40.2%, 95% CI 32.0%, 49.0%, 22 studies, 912 patients). This difference remained after correcting for age and fracture type. Fracture stability (41 studies, 1917 patients), although numerically favoring surgery, did not appear to differ between treatment groups. CONCLUSION: While surgically treated patients showed higher union rates than conservatively treated patients, no clinically relevant differences were observed in NDI, VAS pain, and SWS scores and stability rates. These results need to be further confirmed in well-designed comparative studies with proper adjustment for confounding, such as age, fracture characteristics, and osteoporosis degree.

The effect of weight loss on hypothalamus structure and function in obese individuals: a systematic review and meta-analysis.

INTRODUCTION: Obesity presents with structural and functional hypothalamic dysfunction. However, it is unclear whether weight loss can lead to hypothalamic changes. We therefore aimed to conduct a systematic review and meta-analysis to determine the effect of body mass reduction in obese individuals on hypothalamic structure and function. METHODS: PubMed, Embase and Cochrane databases were searched for studies that reported the change in hypothalamic structure and function after weight loss. Qualitative and quantitative analyses were performed on magnetic resonance imaging techniques, medio-basal hypothalamus T2-relaxation time, blood oxygen level dependent (BOLD) contrast, voxel-based morphometry (VBM) and biomarkers including glucose, insulin, leptin, ghrelin and inflammatory markers of interleukins. Mean differences between pre- and post-weight loss and 95% confidence intervals (CIs) were pooled using random-effects models. RESULTS: Thirteen pre-post studies were included, of which six accounted for the meta-analysis. Studies showed a favorable decrease in T2-relaxation time (n = 1), favorable change in hypothalamic activity after weight loss on BOLD contrast (n = 4), with higher peak activities after surgical weight loss (n = 2). No differences were found in the gray matter density of the hypothalamus on VBM (n = 1). Pooled mean differences between pre- and post-surgical weight loss revealed a decrease of 8.53 mg/dl (95% CI: 5.17, 11.9) in glucose, 7.73 pmol/l (95% CI: 5.07, 10.4) in insulin, 15.5 ng/ml (95% CI: 9.40, 21.6) in leptin, 142.9 pg/ml (95% CI: 79.0, 206.8) in ghrelin and 9.43 pg/ml (95% CI: -6.89, 25.7) in IL-6 level. CONCLUSIONS: Our study showed weight reduction in obesity led to limited structural change and significant functional changes in the hypothalamus.

Complications and cosmetic outcomes of materials used in cranioplasty following decompressive craniectomy-a systematic review, pairwise meta-analysis, and network meta-analysis.

BACKGROUND: Optimal reconstruction materials for cranioplasty following decompressive craniectomy (DC) remain unclear. This systematic review, pairwise meta-analysis, and network meta-analysis compares cosmetic outcomes and complications of autologous bone grafts and alloplasts used for cranioplasty following DC. METHOD: PubMed, Embase, and Cochrane were searched from inception until April 2021. A random-effects pairwise meta-analysis was used to compare pooled outcomes and 95% confidence intervals (CIs) of autologous bone to combined alloplasts. A frequentist network meta-analysis was subsequently conducted to compare multiple individual materials. RESULTS: Of 2033 articles screened, 30 studies were included, consisting of 29 observational studies and one randomized control trial. Overall complications were statistically significantly higher for autologous bone compared to combined alloplasts (RR = 1.56, 95%CI = 1.14-2.13), hydroxyapatite (RR = 2.60, 95%CI = 1.17-5.78), polymethylmethacrylate (RR = 1.50 95%CI = 1.08-2.08), and titanium (Ti) (RR = 1.56 95%CI = 1.03-2.37). Resorption occurred only in autologous bone (15.1%) and not in alloplasts (0.0%). When resorption was not considered, there was no difference in overall complications between autologous bone and combined alloplasts (RR = 1.00, 95%CI = 0.75-1.34), nor between any individual materials. Dehiscence was lower for autologous bone compared to combined alloplasts (RR = 0.39, 95%CI = 0.19-0.79) and Ti (RR = 0.34, 95%CI = 0.15-0.76). There was no difference between autologous bone and combined alloplasts with respect to infection (RR = 0.85, 95%CI = 0.56-1.30), migration (RR = 1.36, 95%CI = 0.63-2.93), hematoma (RR = 0.98, 95%CI = 0.53-1.79), seizures (RR = 0.83, 95%CI = 0.29-2.35), satisfactory cosmesis (RR = 0.88, 95%CI = 0.71-1.08), and reoperation (RR = 1.66, 95%CI = 0.90-3.08). CONCLUSIONS: Bone resorption is only a consideration in autologous cranioplasty compared to bone substitutes explaining higher complications for autologous bone. Dehiscence is higher in alloplasts, particularly in Ti, compared to autologous bone.

Comparison of Amitriptyline and US Food and Drug Administration-Approved Treatments for Fibromyalgia: A Systematic Review and Network Meta-analysis.

Importance: Amitriptyline is an established medication used off-label for the treatment of fibromyalgia, but pregabalin, duloxetine, and milnacipran are the only pharmacological agents approved by the US Food and Drug Administration (FDA) to treat fibromyalgia. Objective: To investigate the comparative effectiveness and acceptability associated with pharmacological treatment options for fibromyalgia. Data Sources: Searches of PubMed/MEDLINE, Cochrane Library, Embase, and Clinicaltrials.gov were conducted on November 20, 2018, and updated on July 29, 2020. Study Selection: Randomized clinical trials (RCTs) comparing amitriptyline or any FDA-approved doses of investigated drugs. Data Extraction and Synthesis: This study follows the Preferred Reporting Items for Systematic Reviews and Meta-analyses reporting guideline. Four independent reviewers extracted data using a standardized data extraction sheet and assessed quality of RCTs. A random-effects bayesian network meta-analysis (NMA) was conducted. Data were analyzed from August 2020 to January 2021. Main Outcomes and Measures: Comparative effectiveness and acceptability (defined as discontinuation of treatment owing to adverse drug reactions) associated with amitriptyline (off-label), pregabalin, duloxetine, and milnacipran (on-label) in reducing fibromyalgia symptoms. The following doses were compared: 60-mg and 120-mg duloxetine; 150-mg, 300-mg, 450-mg, and 600-mg pregabalin; 100-mg and 200-mg milnacipran; and amitriptyline. Effect sizes are reported as standardized mean differences (SMDs) for continuous outcomes and odds ratios (ORs) for dichotomous outcomes with 95% credible intervals (95% CrIs). Findings were considered statistically significant when the 95% CrI did not include the null value (0 for SMD and 1 for OR). Relative treatment ranking using the surface under the cumulative ranking curve (SUCRA) was also evaluated. Results: A total of 36 studies (11 930 patients) were included. The mean (SD) age of patients was 48.4 (10.4) years, and 11 261 patients (94.4%) were women. Compared with placebo, amitriptyline was associated with reduced sleep disturbances (SMD, -0.97; 95% CrI, -1.10 to -0.83), fatigue (SMD, -0.64; 95% CrI, -0.75 to -0.53), and improved quality of life (SMD, -0.80; 95% CrI, -0.94 to -0.65). Duloxetine 120 mg was associated with the highest improvement in pain (SMD, -0.33; 95% CrI, -0.36 to -0.30) and depression (SMD, -0.25; 95% CrI, -0.32 to -0.17) vs placebo. All treatments were associated with inferior acceptability (higher dropout rate) than placebo, except amitriptyline (OR, 0.78; 95% CrI, 0.31 to 1.66). According to the SUCRA-based relative ranking of treatments, duloxetine 120 mg was associated with higher efficacy for treating pain and depression, while amitriptyline was associated with higher efficacy for improving sleep, fatigue, and overall quality of life. Conclusions and Relevance: These findings suggest that clinicians should consider how treatments could be tailored to individual symptoms, weighing the benefits and acceptability, when prescribing medications to patients with fibromyalgia.

Effects of the COVID-19 pandemic on stroke response times: a systematic review and meta-analysis.

OBJECTIVES: COVID-19 presents a risk for delays to stroke treatment. We examined how COVID-19 affected stroke response times. METHODS: A literature search was conducted to identify articles covering stroke during COVID-19 that included time metrics data pre- and post-pandemic. For each outcome, pooled relative change from baseline and 95% CI were calculated using random-effects models. Heterogeneity was explored through subgroup analyses comparing comprehensive stroke centers (CSCs) to non-CSCs. RESULTS: 38 included studies reported on 6109 patients during COVID-19 and 14 637 patients during the pre-COVID period. Pooled increases of 20.9% (95% CI 5.8% to 36.1%) in last-known-well (LKW) to arrival times, 1.2% (-2.9% to 5.3%) in door-to-imaging (DTI), 0.8% (-2.9% to 4.5%) in door-to-needle (DTN), 2.8% (-5.0% to 10.6%) in door-to-groin (DTG), and 19.7% (11.1% to 28.2%) in door-to-reperfusion (DTR) times were observed during COVID-19. At CSCs, LKW increased by 24.0% (-0.3% to 48.2%), DTI increased by 1.6% (-3.0% to 6.1%), DTN increased by 3.6% (1.2% to 6.0%), DTG increased by 4.6% (-5.9% to 15.1%), and DTR increased by 21.2% (12.3% to 30.1%). At non-CSCs, LKW increased by 12.4% (-1.0% to 25.7%), DTI increased by 0.2% (-2.0% to 2.4%), DTN decreased by -4.6% (-11.9% to 2.7%), DTG decreased by -0.6% (-8.3% to 7.1%), and DTR increased by 0.5% (-31.0% to 32.0%). The increases during COVID-19 in LKW (p=0.01) and DTR (p=0.00) were statistically significant, as was the difference in DTN delays between CSCs and non-CSCs (p=0.04). CONCLUSIONS: Factors during COVID-19 resulted in significantly delayed LKW and DTR, and mild delays in DTI, DTN, and DTG. CSCs experience more pronounced delays than non-CSCs.

Intraoperative Magnetic Resonance Imaging for Low-Grade and High-Grade Gliomas: What Is the Evidence? A Meta-Analysis.

BACKGROUND: The benefit of intraoperative magnetic resonance imaging (iMRI) in gliomas remains unclear. We performed a meta-analysis of outcomes with iMRI-guided surgery in high-grade gliomas (HGGs) and low-grade gliomas (LGGs). METHODS: Databases were searched until November 29, 2018 for randomized controlled trials (RCTs) and observational studies (OBS) comparing iMRI use with conventional neurosurgery. Pooled risk ratios (RRs) or hazard ratios were evaluated with the random-effects model. Outcomes included extent of resection (EOR), gross total resection (GTR), progression-free survival (PFS), overall survival (OS), and length of surgery (LOS), stratified by study design and glioma grade. RESULTS: Fifteen articles (3 RCTs and 12 OBS) were included. In RCTs, GTR was higher in iMRI compared with conventional neurosurgery (RR, 1.42; 95% confidence interval [CI], 1.17-1.73; I2, 7%) overall, for LGGs (1.91; 95% CI, 1.19-3.06), but not HGGs (1.24; 95% CI, 0.89-1.73), with no difference in EOR, PFS, OS, and LOS. For OBS, GTR was higher (RR, 1.65; 95% CI, 1.43-1.90; I2, 4%) overall, and for LGGs (1.63; 95% CI, 1.17-2.28; I2, 0%) and HGGs (1.62; 95% CI, 1.36-1.92; I2, 19%). EOR was greater with iMRI (6%; 95% CI, 4%-8%; I2, 44%) overall, in LGGs (5%; 95% CI, 2%-8%; I2, 37%) and HGGs (7%; 95% CI, 4%-10%; I2, 13%). There was no difference in PFS, OS, and LOS with iMRI. CONCLUSIONS: IMRI use improved GTR in gliomas, including LGGs. However, no PFS and OS benefit was shown in the meta-analysis.

The Contribution of Environmental Enrichment to Phenotypic Variation in Mice and Rats.

The reproducibility and translation of neuroscience research is assumed to be undermined by introducing environmental complexity and heterogeneity. Rearing laboratory animals with minimal (if any) environmental stimulation is thought to control for biological variability but may not adequately test the robustness of our animal models. Standard laboratory housing is associated with reduced demonstrations of species typical behaviors and changes in neurophysiology that may impact the translation of research results. Modest increases in environmental enrichment (EE) mitigate against insults used to induce animal models of disease, directly calling into question the translatability of our work. This may in part underlie the disconnect between preclinical and clinical research findings. Enhancing environmental stimulation for our model organisms promotes ethological natural behaviors but may simultaneously increase phenotypic trait variability. To test this assumption, we conducted a systematic review and evaluated coefficients of variation (CVs) between EE and standard housed mice and rats. Given findings of suboptimal reporting of animal laboratory housing conditions, we also developed a methodological reporting table for enrichment use in neuroscience research. Our data show that animals housed in EE were not more variable than those in standard housing. Therefore, environmental heterogeneity introduced into the laboratory, in the form of enrichment, does not compromise data integrity. Overall, human life is complicated, and by embracing such nuanced complexity into our laboratories, we may paradoxically improve on the rigor and reproducibility of our research.

Endoscopic third ventriculostomy versus ventriculoperitoneal shunt in pediatric and adult population: a systematic review and meta-analysis.

Treatment options for hydrocephalus include endoscopic third ventriculostomy (ETV) and ventriculoperitoneal shunt (VPS). Some ambiguity remains regarding indications, safety, and efficacy for these procedures in different clinical scenarios. The objective of the present study was to pool the available evidence to compare outcomes among patients with hydrocephalus undergoing ETV versus VPS. A systematic search of the literature was conducted via PubMed, EMBASE, and Cochrane Library through 11/29/2018 to identify studies evaluating failure and complication rates, following ETV or VPS. Pooled effect estimates were calculated using random effects. Heterogeneity was assessed by the Cochrane Q test and the I2 value. Heterogeneity sources were explored through subgroup analyses and meta-regression. Twenty-three studies (five randomized control trials (RCTs) and 18 observational studies) were meta-analyzed. Comparing ETV to VPS, failure rate was not statistically significantly different with a pooled relative risk (RR) of 1.48, 95%CI (0.85, 2.59) for RCTs and 1.17 (0.89, 1.53) for cohort studies; P-interaction: 0.44. Complication rates were not statistically significantly different between ETV and VPS in RCTs (RR: 1.34, 95%CI: 0.50, 3.59) but were statistically significant for prospective cohort studies (RR: 0.47, 95%CI: 0.30, 0.78); P-interaction: 0.07. Length of hospital stay was no different, when comparing ETV and VPS. These results remained unchanged when stratifying by intervention type and when regressing on age when possible. No significant differences in failure rate were observed between ETV and VPS. ETV was found to have lower complication rates than VPS in prospective cohort studies but not in RCTs. Further research is needed to identify the specific patient populations who may be better suited for one intervention versus another.

Safety and efficacy of prothrombin complex concentrate (PCC) for anticoagulation reversal in patients undergoing urgent neurosurgical procedures: a systematic review and metaanalysis.

Anticoagulant therapy poses a significant risk for patients undergoing emergency neurosurgery procedures, necessitating reversal with prothrombin complex concentrate (PCC) or fresh frozen plasma (FFP). Data on PCC efficacy lack consistency in this setting. This systematic review and metaanalysis aimed to evaluate efficacy and safety of PCC for anticoagulation reversal in the context of urgent neurosurgery. Articles from PubMed, Embase, and Cochrane databases were screened according to the PRISMA checklist. Adult patients receiving anticoagulation reversal with PCC for emergency neurosurgical procedures were included. When available, patients who received FFP were included as a comparison group. Pooled estimates of observational studies were calculated for efficacy and safety outcomes via random-effects modeling. Initial search returned 4505 articles, of which 15 studies met the inclusion criteria. Anticoagulants used included warfarin (83%), rivaroxaban (6.8%), phenprocoumon (6.1%), apixaban (2.2%), and dabigatran (1.5%). The mean International Normalized Ratio (INR) prePCC administration ranged from 2.3 to 11.7, while postPCC administration from 1.1 to 1.4. All-cause mortality at 30 days was 27% (95%CI 21, 34%; I2 = 44.6%; p-heterogeneity = 0.03) and incidence of thromboembolic events was 6.00% among patients treated with PCC (95%CI 4.00, 10.0%; I2 = 0%; p-heterogeneity = 0.83). Results comparing PCC and FFP demonstrated no statistically significant differences in INR reversal, mortality, or incidence of thromboembolic events. This metaanalysis demonstrated adequate safety and efficacy for PCC in the reversal of anticoagulation for urgent neurosurgical procedures. There was no significant difference between PCC and FFP, though further trials would be useful in demonstrating the safety and efficacy of PCC in this setting.

The safety and efficacy of steroid treatment for acute spinal cord injury: A Systematic Review and meta-analysis.

INTRODUCTION: The role for steroids in acute spinal cord injury (ASCI) remains unclear; while some studies have demonstrated the risks of steroids outweigh the benefits,a meta-analyses conducted on heterogeneous patient populations have shown significant motor improvement at short-term but not at long-term follow-up. Given the heterogeneity of the patient population in previous meta-analyses and the publication of a recent trial not included in these meta-analyses, we sought to re-assess and update the safety and short-term and long-term efficacy of steroid treatment following ASCI in a more homogeneous patient population. MATERIALS AND METHODS: A literature search was conducted on PubMed, EMBASE and Cochrane Library through June 2019 for studies evaluating the utility of steroids within the first 8 h following ASCI. Neurological and safety outcomes were extracted for patients treated and not treated with steroids. Pooled effect estimates were calculated using the random-effects model. RESULTS: Twelve studies, including five randomized controlled trials (RCTs) and seven observational studies (OBSs), were meta-analyzed. Overall, methylprednisolone was not associated with significant short-term or long-term improvements in motor or neurological scores based on RCTs or OBSs. An increased risk of hyperglycemia was shown in both RCTs (RR: 13.7; 95% CI: 1.93, 97.4; 1 study) and OBSs (RR: 2.9; 95% CI: 1.55, 5.41; 1 study). Risk for pneumonia was increased with steroids; while this increase was not statistically significant in the RCTs (pooled RR: 1.16; 95% C.I: 0.59, 2.29; 3 studies), it reached statistical significance in the OBSs (pooled RR: 2.00; 95% C.I: 1.32, 3.02; 6 studies). There was no statistically significant increased risk of gastrointestinal bleeding, decubitus ulcers, surgical site infections, sepsis, atelectasis, venous thromboembolism, urinary tract infections, or mortality among steroid-treated ASCI patients compared to untreated controls in either RCTs or OBSs. CONCLUSIONS: Methylprednisolone therapy within the first 8 h following ASCI failed to show a statistically significant short-term or long-term improvement in patients' overall motor or neurological scores compared to controls who were not administered steroids. For the same comparison, there was an increased risk of pneumonia and hyperglycemia compared to controls. Routine use of methylprednisone following ASCI should be carefully considered in the context of these results.

The Safety and Efficacy of Tranexamic Acid in Adult Spinal Deformity Surgery: A Systematic Review and Meta-Analysis.

OBJECTIVES: Major spinal corrective surgeries can be associated with critical intra-operative blood loss. The objective of this systematic review and meta-analysis was to assess the safety and efficacy of tranexamic acid (TXA), a commonly used antifibrinolytic agent, in adult spinal deformity (ASD) surgery, defined as fusion of five or more levels. METHODS: Articles from PubMed, Embase, Cochrane, and clinicaltrials.gov were screened using PRISMA guidelines through December 2018. Thromboembolic events, blood loss, and transfusion levels were primary outcomes of interest. Randomized controlled trials (RCTs) and observational studies (OBSs) with adult patients (≥ 18 years) were included. Continuous variables were analyzed using mean difference (MD) and categorical variables were analyzed using Peto odds ratio (OR), via random effects models. RESULTS: Of the 604 articles screened, seven studies (two RCTs and five cohort studies) were included. Incidence of thromboembolic events was not statistically significantly different between TXA (1 event/19) and placebo (0 events/13) in the RCT (Peto OR = 1.41, 95% CI 0.05-37.2; 32 patients; 1 study) and in the OBSs (TXA [2 events/135] vs control [0 events/72]; Peto OR = 1.09, 95% CI 0.16-7.61; p-heterogeneity = 0.85; 207 patients; 3 studies). Data from OBSs showed that the pooled MD was statistically significantly lower in the TXA group compared with the control group for intraoperative blood loss (MD: - 620.2 mL, 95% CI - 1066.6 to - 173.7; p-heterogeneity = 0.14; 228 patients; 4 studies) and total transfusion volume (MD: - 958.2 mL, 95% CI - 1867.5 to - 49.0; p-heterogeneity = 0.23; 93 patients; 2 studies). CONCLUSION: In this meta-analysis, TXA was not significantly associated with increased risk of thromboembolic events but was associated with lower intraoperative blood loss and lower total transfusion volumes in ASD surgery.

The prevalence of complications associated with lumbar and thoracic spinal deformity surgery in the elderly population: a meta-analysis.

BACKGROUND: The prevalence of spinal deformities increases with age, affecting between 30% and 68% of the elderly population (ages ≥65). The reported prevalence of complications associated with surgery for spinal deformities in this population ranges between 37% and 71%. Given the wide range of reported complication rates, the decision to perform surgery remains controversial. METHODS: A comprehensive search was conducted using PubMed, Embase, and Cochrane to identify studies reporting complications for spinal deformity surgery in the elderly population. Pooled prevalence estimates for individual complication types were calculated using the random-effects model. RESULTS: Of 5,586 articles, 14 met inclusion criteria. Fourteen complication types were reported, with at least 2 studies for each complication with the following pooled prevalence: reoperation (prevalence 19%; 95% CI, 9-36%; 107 patients); hardware failure (11%; 95% CI, 5-25%; 52 patients); infection (7%; 95% CI, 4-12%; 262 patients); pseudarthrosis (6%; 95% CI, 3-12%; 149 patients); radiculopathy (6%; 95% CI, 1-33%; 116 patients); cardiovascular event (5%; 95% CI, 1-32%; 121 patients); neurological deficit (5%; 95% CI, 2-15%; 248 patients); deep vein thrombosis (3%; 95% CI, 1-7%; 230 patients); pulmonary embolism (3%; 95% CI, 1-7%; 210 patients); pneumonia (3%; 95% CI, 1-11%; 210 patients); cerebrovascular or stroke event (2%; 95% CI, 0-9%; 85 patients); death (2%; 95% CI, 1-9%; 113 patients); myocardial infarction (2%; 95% CI, 1-6%; 210 patients); and postoperative hemorrhage (1%; 95% CI, 0-10%; 85 patients). CONCLUSIONS: Most complication types following spinal deformity surgery in the elderly had prevalence point estimates of <6%, while all were at least ≤19%. Additional studies are needed to further explore composite prevalence estimates and prevalence associated with traditional surgical approaches as compared to minimally-invasive procedures in the elderly.

Computed Tomography Angiography Versus Digital Subtraction Angiography for Postclipping Aneurysm Obliteration Detection.

Background and Purpose- Digital subtraction angiography has been used as the gold standard to confirm successful aneurysmal obliteration after aneurysm clipping procedures using titanium or cobalt alloy clips. Computed tomographic angiography is a newer, less invasive imaging technique also used to confirm successful aneurysmal obliteration; however, its use compared with digital subtraction angiography remains controversial. Methods- A comprehensive literature search was conducted on Pubmed, EMBASE, and Cochrane databases through November 6, 2017, for studies that evaluated postclipping aneurysm obliteration with both computed tomographic angiography and digital subtraction angiography. Pooled sensitivity, specificity, positive likelihood ratio (LR+), and negative likelihood ratio (LR-) were calculated using the bivariate random-effects model. Results- Out of 6916 studies, 13 studies met inclusion criteria for this meta-analysis. A total of 510 patients with 613 aneurysms were included. Compared with digital subtraction angiography, which detected 87 residual aneurysms, computed tomographic angiography detected 58 resulting in a pooled sensitivity of 69% (95% CI, 54%-81%) and a pooled specificity of 99% (95% CI, 97%-99%). This corresponded to LR+ of 55.5 (95% CI, 23.6-130.9) and LR- of 0.31 (95% CI, 0.20-0.48). Univariate meta-regression revealed that the pooled sensitivity was worse in prospective designs ( P interaction <0.05), and the pooled specificity was better in higher-quality studies and for postoperative aneurysm diameters of <2 mm ( P interaction <0.001 for both). Conclusions- This meta-analysis revealed that computed tomographic angiography had a favorable LR+ but not a favorable LR-. Thus, this imaging modality may be applicable to rule in, but not rule out, residual aneurysms after clipping.

Fertility after transsphenoidal surgery in patients with prolactinomas: A meta-analysis.

Pituitary prolactinomas in women often lead to amenorrhea, galactorrhea, or infertility. The purpose of this study was to evaluate the effectiveness of transsphenoidal surgery (TSS) in restoring fertility in women with proloactinomas. A systematic search of the literature was conducted in accordance with PRISMA guidelines through 6/13/2017. PubMed, Embase, and Cochrane databases were utilized to select studies reporting on patients with pituitary prolactinomas removed via TSS. Outcomes extracted included pre- and post-operative rates of menses, lactation, and fertility. Pooled effect estimates were calculated using random-effects. After removal of duplicates, 900 articles remained, of which 14 were meta-analyzed. The mean difference between pre- and post-operative prolactin level was 186.9 (95% CI = 133.7, 240.1; I2 = 69.9%; P-heterogeneity<0.01; 7 studies). The pooled prevalence of pre-operative amenorrhea was 96% (95% CI = 92%, 98%; I2 = 45.8%; P-heterogeneity = 0.09; 11 studies) and significantly larger than post-operative amenorrhea of 40% (95% CI = 27%, 55%; P- I2 = 85%; heterogeneity<0.01; 11 studies); (P-interaction comparing the 2 groups <0.01). The pooled prevalence of pre-operative galactorrhea was 84% (95% CI = 74%, 90%; I2 = 66.9%; P-heterogeneity<0.01; 10 studies) and significantly larger than post-operative galactorrhea of 29% (95% CI = 17%, 44%; I2 = 76.5%; P-heterogeneity<0.01; 7 studies) (P-interaction<0.01). Univariate meta-regression on age, continent, publication year, study design, quality, duration, or timing revealed these covariates were not effect modifiers for any of the 3 outcomes (all P > 0.05). No evidence of publication bias was seen using Begg's and Egger's tests (all P > 0.05). Transsphenoidal surgery appeared to improve fertility measures in women with pituitary prolactinomas.

Systematic reviews and tech mining: A methodological comparison with case study.

When the Medical Library Association identified questions critical for the future of the profession, it assigned groups to use systematic reviews to find the answers to these questions. Group 6, whose question was on emerging technologies, recognized early on that the systematic review process would not work well for this question, which looks forward to predict future trends, whereas the systematic review process looks back in time. We searched for new methodologies that were more appropriate to our question, developing a process that combined systematic review, text mining, and visualization techniques. We then discovered tech mining, which is very similar to the process we had created. In this paper, we describe our research design and compare tech mining and systematic review methodologies. There are similarities and differences in each process: Both use a defined research question, deliberate database selection, careful and iterative search strategy development, broad data collection, and thoughtful data analysis. However, the focus of the research differs significantly, with systematic reviews looking to the past and tech mining mainly to the future. Our comparison demonstrates that each process can be enhanced from a purposeful consideration of the procedures of the other. Tech mining would benefit from the inclusion of a librarian on their research team and a greater attention to standards and collaboration in the research project. Systematic reviews would gain from the use of tech mining tools to enrich their data analysis and corporate management communication techniques to promote the adoption of their findings.

A prognostic role for Low tri-iodothyronine syndrome in acute stroke patients: A systematic review and meta-analysis.

BACKGROUND: Low triiodothyronine (T3) syndrome could be a powerful prognostic factor for acute stroke; yet, a prognostic role for low T3 has not been given enough importance in stroke management. This meta-analysis aimed to evaluate whether low T3 among acute stroke patients could be used as a prognostic biomarker for stroke severity, functional outcome, and mortality. METHODS: Studies that investigated low T3 prognostic roles in acute stroke patients were sought from PubMed/Medline, Embase, and Cochrane databases through 11/23/2016. Pooled estimates of baseline stroke severity, mortality, and functional outcomes were assessed from fixed-effect (FE) and random-effects (RE) models. RESULTS: Eighteen studies met the inclusion criteria. Six studies (1,203 patients) provided data for low-T3 and normal-T3 patients and were meta-analyzed. Using the FE model, pooled results revealed low-T3 patients exhibited a significantly higher stroke severity, as assessed by the National Institutes of Health Stroke Scale (NIHSS) score at admission (mean difference = 3.18; 95%CI = 2.74, 3.63; I2 = 61.9%), had 57% higher risk of developing poor functional outcome (RR = 1.57; 95%CI = 1.33,1.8), and had 83% higher odds of mortality (Peto-OR = 1.83; 95%CI = 1.21, 1.99) compared to normal-T3 patients. In a univariate meta-regression analysis, the low-T3 and stroke severity association was reduced in studies with higher smokers% (slope = -0.11; P = 0.02), higher hypertension% (slope = -0.11; P = 0.047), older age (slope = -0.54; P = 0.02), or longer follow-up (slope = -0/17, P < 0.01). RE models yielded similar results. No significant publication bias was observed for either outcome using Begg's and Egger's tests. CONCLUSIONS: Low-T3 syndrome in acute stroke patients is an effective prognostic factor for predicting greater baseline stroke severity, poorer functional outcome, and higher overall mortality risk.

Coiling Versus Microsurgical Clipping in the Treatment of Unruptured Middle Cerebral Artery Aneurysms: A Meta-Analysis.

BACKGROUND: Open microsurgical clipping of unruptured intracranial aneurysms has long been the gold standard, yet advancements in endovascular coiling techniques have begun to challenge the status quo. OBJECTIVE: To compare endovascular coiling with microsurgical clipping among adults with unruptured middle cerebral artery aneurysms (MCAA) by conducting a meta-analysis. METHODS: A systematic search was conducted from January 2011 to October 2015 to update a previous meta-analysis. All studies that reported unruptured MCAA in adults treated by microsurgical clipping or endovascular coiling were included and cumulatively analyzed. RESULTS: Thirty-seven studies including 3352 patients were included. Using the random-effects model, pooled analysis of 11 studies of microsurgical clipping (626 aneurysms) revealed complete aneurysmal obliteration in 94.2% of cases (95% confidence interval [CI] 87.6%-97.4%). The analysis of 18 studies of endovascular coiling (759 aneurysms) revealed complete obliteration in 53.2% of cases (95% CI: 45.0%-61.1%). Among clipping studies, 22 assessed neurological outcomes (2404 aneurysms), with favorable outcomes in 97.9% (95% CI: 96.8%-98.6%). Among coiling studies, 22 examined neurological outcomes (826 aneurysms), with favorable outcomes in 95.1% (95% CI: 93.1%-96.5%). Results using the fixed-effect models were not materially different. CONCLUSION: This updated meta-analysis demonstrates that surgical clipping for unruptured MCAA remains highly safe and efficacious. Endovascular treatment for unruptured MCAAs continues to improve in efficacy and safety; yet, it results in lower rates of occlusion.

Headache Resolution After Rathke Cleft Cyst Resection: A Meta-Analysis.

OBJECTIVE: Rathke cleft cysts (RCC) are benign lesions of the sella that often present with headache. It is not currently well established whether surgical resection of RCC results in resolution of headache. We conducted a meta-analysis to examine the effect of RCC resection on headache resolution. METHODS: PubMed, EMBASE, and Cochrane databases were searched through June 2017 for articles that evaluated the effect of RCC resection on headache resolution. Pooled effect estimates were calculated using fixed-effects and random-effects models. RESULTS: Ten case series with 276 patients were included. Transsphenoidal surgery (TSS) was used to resect RCC in all of the studies. Only 1 patient in 1 study underwent transcranial surgery. Using the fixed effect model, the overall headache resolution prevalence was 71.7% (95% confidence interval [CI] 65.3%, 77.3%) among patients who underwent resection of RCC (I2 = 76.9%; P-heterogeneity < 0.01). Subgroup analysis based on center (P-interaction < 0.01) and continent (P < 0.01) showed a higher resolution in studies conducted in a single center (79.8%; 95% CI 73.7%, 84.8%) than in multiple centers (40.0%; 95% CI 26.9%, 54.8%) and a higher resolution in studies conducted in Asia (85.0%) than in Europe (61.5%) or North America (65.7%). Metaregression analysis was significant on mean follow-up time (slope = 0.03; P = 0.02), percentage of women (slope -0.05; P < 0.01), journal impact factor (slope 0.73; P < 0.01), and study quality (slope -0.99; P < 0.01) but not on mean age (P = 0.10). None of the above-mentioned results were significant when the random effects model was used. No evidence of publication bias was observed. CONCLUSION: This meta-analysis demonstrates that the resection of RCC in patients presenting with headache is associated with headache resolution.