Appropriateness and Quality of Composite Endpoint Use and Reporting in Spine Surgery: A Systematic Review.

BACKGROUND: A composite endpoint (CEP) is a measure comprising 2 or more separate component outcomes. The use of these constructs is increasing. We sought to conduct a systematic review on the usage, quality of reporting, and appropriate use of CEPs in spine surgery research. METHODS: A systematic review was conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. Articles reporting randomized controlled trials of a spine surgery intervention using a CEP as a primary outcome were included. We assessed the quality of CEP reporting, appropriateness of CEP use, and correspondence between CEP treatment effect and component outcome treatment effect in the included trials. RESULTS: Of 2,321 initial titles, 43 citations were included for analysis, which reported on 20 unique trials. All trials reported the CEP construct well. In 85% of trials, the CEP design was driven by US Food and Drug Administration guidance. In the majority of trials, the reporting of CEP results did not adhere to published recommendations: 43% of tests that reported statistically significant results on component outcomes were not statistically significant when adjusted for multiple testing. 67% of trials did not meet appropriateness criteria for CEP use. In addition, CEP treatment effect tended to be 6% higher than the median treatment effect for component outcomes. CONCLUSION: Given that CEP analysis was not appropriate for the majority of spine surgery trials and the inherent challenges in the reporting and interpretation of CEP analysis, CEP use should not be mandated by regulatory bodies in spine surgery trials. LEVEL OF EVIDENCE: Level I. See Instructions for Authors for a complete description of levels of evidence.

Applications of Machine Learning in Prognostication of mTBI: A Systematic Review.

OBJECTIVE: To review the literature regarding the current state and clinical applicability of machine learning (ML) models in prognosticating the outcomes of patients with mild traumatic brain injury (mTBI) in the early clinical presentation. DESIGN: Databases were searched for studies including ML and mTBI from inception to March 10, 2023. Included studies had a primary outcome of predicting post-mTBI prognosis or sequalae. The Prediction model study Risk of Bias for Predictive Models assessment tool (PROBAST) was used for assessing the risk of bias and applicability of included studies. RESULTS: Out of 1235 articles, 10 met the inclusion criteria, including data from 127,929 patients. The most frequently used modeling techniques were Support Vector Machine (SVM) and Artificial Neural Network (NN) and Area Under the Curve (AUC) ranged from 0.66-0.889. Despite promise, several limitations to studies exist such as low sample sizes, database restrictions, inconsistencies in patient presentation definitions and lack of comparison to traditional clinical judgment or tools. CONCLUSION: ML models show potential in early stage mTBI prognostication, but to achieve widespread adoption, future clinical studies prognosticating mTBI using ML need to reduce bias, provide clarity and consistency in defining patient populations targeted, and validate against established benchmarks.

The Development And Applications Of Augmented And Virtual Reality Technology In Spine Surgery Training: A Systematic Review.

BACKGROUND: The COVID-19 pandemic has accelerated the growing global interest in the role of augmented and virtual reality in surgical training. While this technology grows at a rapid rate, its efficacy remains unclear. To that end, we offer a systematic review of the literature summarizing the role of virtual and augmented reality on spine surgery training. METHODS: A systematic review of the literature was conducted on May 13th, 2022. PubMed, Web of Science, Medline, and Embase were reviewed for relevant studies. Studies from both orthopedic and neurosurgical spine programs were considered. There were no restrictions placed on the type of study, virtual/augmented reality modality, nor type of procedure. Qualitative data analysis was performed, and all studies were assigned a Medical Education Research Study Quality Instrument (MERSQI) score. RESULTS: The initial review identified 6752 studies, of which 16 were deemed relevant and included in the final review, examining a total of nine unique augmented/virtual reality systems. These studies had a moderate methodological quality with a MERSQI score of 12.1 + 1.8; most studies were conducted at single-center institutions, and unclear response rates. Statistical pooling of the data was limited by the heterogeneity of the study designs. CONCLUSION: This review examined the applications of augmented and virtual reality systems for training residents in various spine procedures. As this technology continues to advance, higher-quality, multi-center, and long-term studies are required to further the adaptation of VR/AR technologies in spine surgery training programs.

Systematic Review and Meta-Analysis of Randomized Controlled Trials for Scalp Block in Craniotomy.

BACKGROUND: Scalp block is regional anesthetic injection along nerves innervating the cranium. Scalp blocks for craniotomy may decrease postoperative pain and opioid consumption. Benefits may extend beyond the anesthetic period. OBJECTIVE: To analyze evidence for scalp block on postoperative pain and opioid use. METHODS: This systematic review and meta-analysis, Prospective Register of Systematic Reviews registration (CRD42022308048), included Ovid Medical Literature Analysis and Retrieval System Online, Embase, and Cochrane Central Register of Controlled Trials inception through February 9, 2022. Only randomized controlled trials were included. We excluded studies not reporting either main outcome. Duplicate reviewers performed study selection, risk of bias assessment, data extraction, and evidence certainty Grading of Recommendations Assessment, Development, and Evaluation appraisal. Main outcomes were postoperative pain by visual analog scale within 72 hours and opioid consumption as morphine milligram equivalent (MME) within 48 hours. RESULTS: Screening filtered 955 studies to 23 trials containing 1532 patients. Risk of bias was overall low. Scalp block reduced postoperative pain at 2 through 72 hours, visual analog scale mean differences of 0.79 to 1.40. Opioid requirements were reduced at 24 hours by 16.52 MME and 48 hours by 15.63 MME. CONCLUSION: Scalp block reduces postoperative pain at 2 through 48 hours and may reduce pain at 72 hours. Scalp block likely reduces opioid consumption within 24 hours and may reduce opioid consumption to 48 hours. The clinical utility of these differences should be interpreted within the context of modest absolute reductions, overall care optimization, and patient populations. This is the first level 1A evidence to evaluate scalp block efficacy in craniotomy.

Digest: Evolution of a robust phenotype in Drosophila.

Do developmentally robust phenotypes evolve over the evolutionary history of a genus, and if so, how? Kalay et al. found that segmentation along the head to tail axis, a robust phenotype, has evolved in Drosophila over the evolutionary history of the genus, primarily through many small changes.