ABSTRACT
BACKGROUND: The ketogenic diet (KD) is a high-fat, low-carbohydrate diet with therapeutic potential in refractory seizures, both in outpatient and inpatient settings. Successful implementation of KD involves a multifaceted, interdisciplinary approach to address anticipated challenges. We sought to characterize the utilization of KD among healthcare providers caring for adults with status epilepticus (SE). METHODS: We distributed a web-based survey through professional societies, including the American Academy of Neurology (AAN), Neurocritical Care Society (NCS), American Epilepsy Society (AES), Neuro Anesthesia and Critical Care Society (NACCS), and the Academy of Nutrition and Dietetics (AND), and via research contacts. We asked respondents about practice experience and experience using KD as a treatment for SE. Descriptive statistics and Chi-square tests were used to analyze the results. RESULTS: Of 156 respondents, 80% of physicians and 18% of non-physicians reported experience with KD for SE. Anticipated difficulty in achieving ketosis (36.3%), lack of expertise (24.2%), and lack of resources (20.9%) were identified as the most important barriers limiting the utilization of KD. The absence of dietitians (37.1%) or pharmacists (25.7%) support was the most important missing resource. Reasons for stopping KD included perceived ineffectiveness (29.1%), difficulty achieving ketosis (24.6%), and side effects (17.3%). Academic centers had more experience with the use of KD and greater EEG monitoring availability and fewer barriers to its implementation. The need for randomized clinical trials supporting efficacy (36.5%) and better practice guidelines for implementation and maintenance of KD (29.6%) were cited most frequently as factors to increase utilization of KD. CONCLUSION: This study identifies important barriers to the utilization of KD as a treatment for SE despite evidence supporting its efficacy in the appropriate clinical context, namely lack of resources and interdisciplinary support, and lack of established practice guidelines. Our results highlight the need for future research to improve understanding of the efficacy and safety of KD along with better interdisciplinary collaborations to increase its utilization.
Subject(s)
Diet, Ketogenic , Epilepsy , Ketosis , Status Epilepticus , Humans , Adult , Diet, Ketogenic/methods , Status Epilepticus/drug therapy , Diet, Carbohydrate-Restricted/methods , Treatment OutcomeABSTRACT
OBJECTIVES: Large-scale procedural safety data on pterygopalatine fossa nerve blocks (PPFBs) performed via a suprazygomatic, ultrasound-guided approach are lacking, leading to hesitancy surrounding this technique. The aim of this study was to characterize the safety of PPFB. METHODS: This retrospective chart review examined the records of adults who received an ultrasound-guided PPFB between January 1, 2016, and August 30, 2020, at the University of Florida. Indications included surgical procedures and nonsurgical pain. Clinical data describing PPFB were extracted from medical records. Descriptive statistics were calculated for all variables, and quantitative variables were analyzed with the paired t test to detect differences between before and after the procedure. RESULTS: A total of 833 distinct PPFBs were performed on 411 subjects (59% female, mean age 48.5 years). Minor oozing from the injection site was the only reported side effect, in a single subject. Although systolic blood pressure, heart rate, and oxygen saturation were significantly different before and after the procedure (132.3 vs 136.4 mm Hg, P < 0.0001; 78.2 vs 80.8, P = 0.0003; and 97.8% vs 96.3%, P < 0.0001; respectively), mean arterial pressure and diastolic blood pressure were not significantly different (96.2 vs 97.1 mm Hg, P = 0.1545, and 78.2 vs 77.4 mm Hg, P = 0.1314, respectively). Similar results were found within subgroups, including subgroups by sex, race, and indication for PPFB. DISCUSSION: We have not identified clinically significant adverse effects from PPFB performed with an ultrasound-guided suprazygomatic approach in a large cohort in the hospital setting. PPFBs are a safe and well-tolerated pain management strategy; however, prospective multicenter studies are needed.
Subject(s)
Nerve Block , Pterygopalatine Fossa , Adult , Female , Humans , Male , Middle Aged , Nerve Block/methods , Prospective Studies , Pterygopalatine Fossa/diagnostic imaging , Retrospective Studies , Ultrasonography, Interventional/methodsABSTRACT
INTRODUCTION AND OBJECTIVES: There is no consensus on the best treatment option for choledocholithiasis. Therefore, the aim of this study was to compare endoscopic retrograde cholangiopancreatography (ERCP) and common bile duct surgery (CBDS) for the treatment of choledocholithiasis. MATERIALS AND METHODS: We performed a systematic review of randomized controlled trials (RCTs) comparing ERCP and CBDS in the treatment of choledocholithiasis. MEDLINE and EMBASE were the used databases. RCTs assessing mortality, bile duct clearance failure, complications, or length of hospital stay were considered eligible. Meta-analysis was performed using random effects model, through the Mantel-Haenszel method for binary outcomes and through the inverse variance method for continuous outcomes. The quality of the evidence was evaluated according to the Grading of Recommendations Assessment, Development and Evaluation Working Group. The study protocol was registered at the PROSPERO platform (CRD42017073196). RESULTS: Nineteen RCTs (2466 patients) were included in the meta-analysis. There was no evidence of significant difference between interventions regarding mortality (risk ratio - RR=1.31, 95% confidence interval - 95% CI=0.60-2.85, p=0.49), bile duct clearance failure (RR=1.17, 95% CI=0.86-1.59, p=0.31), complications (RR=0.99, 95% CI=0.82-1.20, p=0.94) and length of hospital stay (weighted mean difference - MD=1.06, 95% CI=-0.62-2.73, p=0.22). Sensitivity analyses failed to demonstrate significant changes in results compared to the main analyses. The quality of the evidence was considered to be low. CONCLUSION: There was no evidence of significant difference between ERCP and CBDS for the treatment of choledocholithiasis.
Subject(s)
Biliary Tract Surgical Procedures/methods , Cholangiopancreatography, Endoscopic Retrograde/methods , Choledocholithiasis/surgery , Common Bile Duct/surgery , Humans , Length of Stay/statistics & numerical data , Mortality , Postoperative Complications/epidemiology , Randomized Controlled Trials as Topic , Treatment OutcomeABSTRACT
Background: Headache management after acute brain injury (ABI) is challenging. While opioids are commonly used, selective cyclooxygenase-2 inhibitors (COXIBs) may be promising alternatives. However, concerns about cardiovascular effects and bleeding risk have limited their use. We aimed at summarizing available data on efficacy of COXIBs for headache management following ABI. Methods: A systematic review was conducted through MEDLINE and Embase for articles published through 09/2023 (PROSPERO CRD42022320453). No language filters were applied to the initial searches. Interventional or observational studies and systematic reviews assessing efficacy of COXIBs for headache in adults with ABI were eligible. Article selection was performed by two independent reviewers using Distiller SR®. Descriptive statistics were used for data analysis, while meta-analysis was unfeasible due to study heterogeneity. Results: Of 3190 articles identified, six studies met inclusion criteria: four randomized controlled trials and two retrospective cohort studies, all conducted in neurosurgical patients (total n=738) between 2006-2022. Five studies used COXIBs in the intervention group only. Of the six studies, four found a reduction in overall pain scores in the intervention group, while one showed improvement only at 6 hours postoperative, and one did not find significant differences. Pain scores decreased between 4-15%, the largest shift being from moderate to mild severity. Three studies found an overall opioid use reduction throughout hospitalization in the intervention group, while one reported a reduction at 12 hours postoperative only. Opioid consumption decreased between 9-90%. Two studies found a decrease in hospital-length-of-stay by ~1 day in the intervention group. The one study reporting postoperative hemorrhage found a statistically non-significant 3% reduction in the intervention group. Conclusions: In adults with ABI, COXIBs may serve as opioid-sparing adjunctive analgesics for headache control, with limited but pointed data to indicate efficacy in the post-neurosurgical setting. However, further safety data remains to be elucidated.
ABSTRACT
Self-fulfilling prophecy bias occurs when a perceived prognosis leads to treatment decisions that inherently modify outcomes of a patient, and thus, overinflate the prediction performance of prognostic methods. The goal of this series of systematic reviews is to characterize the extent to which neuroprognostic studies account for the potential impact of self-fulfilling prophecy bias in their methodology by assessing their adequacy of disclosing factors relevant to this bias. Methods: Studies evaluating the prediction performance of neuroprognostic tools in cardiac arrest, malignant ischemic stroke, traumatic brain injury, subarachnoid hemorrhage, and spontaneous intracerebral hemorrhage will be identified through PubMed, Cochrane, and Embase database searches. Two reviewers blinded to each other's assessment will perform screening and data extraction of included studies using Distiller SR and following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We will abstract data pertinent to the methodology of the studies relevant to self-fulfilling prophecy bias. Results: We will conduct a descriptive analysis of the data. We will summarize the reporting of mortality according to timing and mode of death, rates of exposure to withdrawal of life-sustaining therapy, reasoning behind limitations of supportive care, systematic use of standardized neuroprognostication algorithms and whether the tool being investigated is part of such assessments, and blinding of treatment team to results of neuroprognostic test being evaluated. CONCLUSIONS: We will identify if neuroprognostic studies have been transparent in their methodology to factors that affect the self-fulfilling prophecy bias. Our results will serve as the foundation for standardization of neuroprognostic study methodologies by refining the quality of the data derived from such studies.
ABSTRACT
BACKGROUND: Nearly one in three unconscious cardiac arrest survivors experience post-anoxic status epilepticus (PASE). Historically, PASE has been deemed untreatable resulting in its exclusion from status epilepticus clinical trials. However, emerging reports of survivors achieving functional independence following early and aggressive treatment of PASE challenged this widespread therapeutic nihilism. In the absence of proven therapies specific to PASE, standard of care treatment leans on general management strategies for status epilepticus. Vigabatrin-an approved therapy for refractory focal-onset seizures in adults-inhibits the enzyme responsible for GABA catabolism, increases brain GABA levels and may act synergistically with anesthetic agents to abort seizures. Our central hypothesis is that early inhibition of GABA breakdown is possible in the post-cardiac arrest period and may be an effective adjunctive treatment in PASE. METHODS: This is a phase IIa, single-center, open-label, pilot clinical trial with blinded outcome assessment, of a single dose of vigabatrin in 12 consecutive PASE subjects. Subjects will receive a single loading dose of 4500 mg of vigabatrin (or dose adjusted in moderate and severe renal impairment) via enteric tube within 48 h of PASE onset. Vigabatrin levels will be monitored at 0- (baseline), 0.5-, 1-, 2-, 3-, 6-, 12-, 24-, 48-, 72- and 168-h (7 days) post-vigabatrin. Serum biomarkers of neuronal injury will be measured at 0-, 24-, 48-, 72- and 96-h post-vigabatrin. The primary feasibility endpoint is the proportion of enrolled subjects among identified eligible subjects receiving vigabatrin within 48 h of PASE onset. The primary pharmacokinetic endpoint is the measured vigabatrin level at 3 h post-administration. Descriptive statistics with rates and proportions will be obtained regarding feasibility outcomes, along with the noncompartmental method for pharmacokinetic analyses. The area under the vigabatrin concentration-time curve in plasma from zero to the time of the last quantifiable concentration (AUC0-tlqc) will be calculated to estimate dose-linear pharmacokinetics. PERSPECTIVE: Vigabatrin demonstrates high potential for synergism with current standard of care therapies. Demonstration of the feasibility of vigabatrin administration and preliminary safety in PASE will pave the way for future efficacy and safety trials of this pharmacotherapeutic. Trial Registration NCT04772547.