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Pain Physician Nov 2023Various regulations and practice patterns develop on the basis of Local Coverage Determination (LCD), which are variably perceived as guidelines and/or mandated polices/...
BACKGROUND
Various regulations and practice patterns develop on the basis of Local Coverage Determination (LCD), which are variably perceived as guidelines and/or mandated polices/ regulations. LCDs developed in 2021 and effective since December 2021 mandated a minimum of 2 views for final needle placement with contrast injection which includes both anteroposterior (AP) and lateral or oblique view. Radiation safety has been a major concern for pain physicians and multiple tools have been developed to reduce radiation dose, along with improvement in technologies to limit radiation exposure while performing fluoroscopically guided interventional procedures, with implementation of principles of As Low As Reasonably Achievable (ALARA). The mandated 2 views of epidural injections have caused concern among some physicians, because of the potential of increased exposure to ionizing radiation, despite application of various principles to minimize radiation exposure. Others, including policymakers are of the opinion that it reduces potential abuse and improves safety.
OBJECTIVE
To assess variations in the performance of epidural procedures prior to the implementation of the new LCD compared with after the implementation of the new LCD by comparing time and dosage for all types of epidural procedures.
STUDY DESIGN
A retrospective, case controlled, comparative evaluation of radiation exposure during epidural procedures in interventional pain management.
SETTING
An interventional pain management practice and a specialty referral center in a private practice setting in the United States.
METHODS
The study was performed using the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) criteria. The main outcome measure was radiation exposure time measured in seconds and dose measured in mGy-kG2 (milligray to kilogray squared per procedure).
RESULTS
Changes in exposure and dose varied by procedural type and location. Exposure time in seconds increased overall by 21%, whereas radiation dose mGy-kG increased 133%. Fluoroscopy time increased most for lumbar interlaminar epidural injections of 43%, followed by 29% for cervical interlaminar epidural injections, 20% for caudal epidural injections, and 14% for lumbar transforaminal epidural injections. In contrast, highest increases were observed in the radiation dose mGy of 191% for caudal epidural injections, followed by 173% for lumbar interlaminar epidural injections, 113% for lumbar transforaminal epidural injections, and the lowest being cervical interlaminar epidural injections of 94%. This study also shows lesser increases for cervical interlaminar epidural injections because an oblique view is utilized rather than a lateral view resulting in a radiation dosage increase of 94% compared to overall increase of 133%, whereas the duration of time of 29% was higher than the overall combined duration of all procedures which only increased by 21%.
LIMITATIONS
A retrospective evaluation utilizing the experience of a single physician.
CONCLUSION
The results of this study showed significant increases in radiation exposure time and dosage; however, increase of dosage was overall 21% median Interquartile Range (IQR) compared to 133% of radiation dose median IQR. In addition, the results also showed variations for procedure, overall showing highest increases for lumbar interlaminar epidural injections for time (43%) and caudal epidural injections for dosage (191%).
Topics: Humans; Retrospective Studies; Pain; Injections, Epidural; Radiation Exposure; Fluoroscopy
PubMed: 37976484
DOI: No ID Found -
Journal of Investigative Surgery : the... Dec 2024To compare the clinical and radiological results of the anterior approach versus the posterior approach versus the anterior-posterior approach for the treatment of... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
To compare the clinical and radiological results of the anterior approach versus the posterior approach versus the anterior-posterior approach for the treatment of thoracolumbar burst fractures.
METHODS
The network meta-analysis was performed in accordance with the PRISMA Statement. Electronic searches of PubMed and Embase were conducted up to June 22, 2023, for relevant randomized controlled trials. STATA13.0 was used to perform network meta-analysis. < .05 was considered significant.
RESULTS
Nine RCTs with a total of 550 patients receiving surgical treatment in at least two of the three approaches, including anterior, posterior and anterior-posterior approaches, were included. The surgical duration and intraoperative bleeding volume in the posterior approach were significantly lower than those in the anterior (SMD, -1.72; 95% CI, -2.82, -0.62) and anterior-posterior approaches (SMD, 3.33; 95% CI, 1.65, 5.00). The surgical duration in the anterior approach was significantly lower than that in the anterior-posterior approach (SMD, 1.61; 95% CI, 0.12, 3.10). The Cobb angle in the anterior-posterior approach was significantly lower than that in the anterior approach (MD, -4.83; 95% CI, -9.60, -0.05). The VAS score in the posterior approach was significantly higher than that in the anterior approach (MD, 0.85; 95% CI, 0.55, 1.16) and anterior-posterior approach (MD, -0.84; 95% CI, -1.12, -0.55). No significant difference was identified among the three surgical approaches in implant failure rate and infection rate.
CONCLUSION
All three approaches were safe approaches with advantages and disadvantages. The selection of surgical approaches for the treatment of thoracolumbar burst fractures may be individualized.
Topics: Humans; Network Meta-Analysis; Randomized Controlled Trials as Topic; Fractures, Comminuted
PubMed: 38199978
DOI: 10.1080/08941939.2024.2301794 -
Dental Materials : Official Publication... Sep 2023The present in vitro study aimed to evaluate the accuracy of three-dimensional (3D) printed indirect bonding trays consisting of hard or soft resin materials produced...
OBJECTIVES
The present in vitro study aimed to evaluate the accuracy of three-dimensional (3D) printed indirect bonding trays consisting of hard or soft resin materials produced using computer-aided design and manufacturing (CAD/CAM).
METHODS
Forty-eight dental casts were 3D printed. Four groups based on frontal crowding were defined and divided into hard- and soft-resin groups. After virtual bracket positioning on the digital models, the transfer trays were 3D printed. To evaluate the accuracy of the procedure, measurements were performed using a digital overlay of the virtual (target) bracket position and a post-bonding scan. The horizontal, transverse, and vertical deviations and angular discrepancies were analyzed. The loss rate was evaluated descriptively as a percentage.
RESULTS
A total of 553 brackets were bonded using 24 soft and 24 resilient indirect bonding trays. The mean deviations were of 0.05 mm (transversal), 0.05 mm (horizontal), 0.09 mm (vertical), 0.13° (angulation) in the resilient resin group and of 0.01 mm (transversal), 0.08 mm (horizontal), 0.08 mm (vertical), 0.37° (angular) in the soft resin group. The loss rate was 6.9% and 0.7% in the hard and soft resin groups, respectively. Angular deviations were significantly higher in the soft resin group (P = 0.009), whereas the loss rate was considerably higher in the hard resin group (P < 0.001).
SIGNIFICANCE
The findings indicate that indirect bonding using CAD/CAM is an accurate procedure in the laboratory setting. Soft resins are considered favorable for loss rate and useability.
Topics: Computer-Aided Design; Dental Bonding; Models, Dental; Orthodontic Brackets; Research Design; Single-Blind Method
PubMed: 37482433
DOI: 10.1016/j.dental.2023.07.003 -
Biometrics Dec 2023The problem of how to best select variables for confounding adjustment forms one of the key challenges in the evaluation of exposure effects in observational studies,...
The problem of how to best select variables for confounding adjustment forms one of the key challenges in the evaluation of exposure effects in observational studies, and has been the subject of vigorous recent activity in causal inference. A major drawback of routine procedures is that there is no finite sample size at which they are guaranteed to deliver exposure effect estimators and associated confidence intervals with adequate performance. In this work, we will consider this problem when inferring conditional causal hazard ratios from observational studies under the assumption of no unmeasured confounding. The major complication that we face with survival data is that the key confounding variables may not be those that explain the censoring mechanism. In this paper, we overcome this problem using a novel and simple procedure that can be implemented using off-the-shelf software for penalized Cox regression. In particular, we will propose tests of the null hypothesis that the exposure has no effect on the considered survival endpoint, which are uniformly valid under standard sparsity conditions. Simulation results show that the proposed methods yield valid inferences even when covariates are high-dimensional.
Topics: Bias; Computer Simulation; Proportional Hazards Models; Sample Size; Software
PubMed: 37349873
DOI: 10.1111/biom.13889 -
BMC Medical Research Methodology Oct 2023Adaptive clinical trials are growing in popularity as they are more flexible, efficient and ethical than traditional fixed designs. However, notwithstanding their...
BACKGROUND
Adaptive clinical trials are growing in popularity as they are more flexible, efficient and ethical than traditional fixed designs. However, notwithstanding their increased use in assessing treatments for COVID-19, their use in critical care trials remains limited. A better understanding of the relative benefits of various adaptive designs may increase their use and interpretation.
METHODS
Using two large critical care trials (ADRENAL.
CLINICALTRIALS
gov number, NCT01448109. Updated 12-12-2017; NICE-SUGAR.
CLINICALTRIALS
gov number, NCT00220987. Updated 01-29-2009), we assessed the performance of three frequentist and two bayesian adaptive approaches. We retrospectively re-analysed the trials with one, two, four, and nine equally spaced interims. Using the original hypotheses, we conducted 10,000 simulations to derive error rates, probabilities of making an early correct and incorrect decision, expected sample size and treatment effect estimates under the null scenario (no treatment effect) and alternative scenario (a positive treatment effect). We used a logistic regression model with 90-day mortality as the outcome and the treatment arm as the covariate. The null hypothesis was tested using a two-sided significance level (α) at 0.05.
RESULTS
Across all approaches, increasing the number of interims led to a decreased expected sample size. Under the null scenario, group sequential approaches provided good control of the type-I error rate; however, the type I error rate inflation was an issue for the Bayesian approaches. The Bayesian Predictive Probability and O'Brien-Fleming approaches showed the highest probability of correctly stopping the trials (around 95%). Under the alternative scenario, the Bayesian approaches showed the highest overall probability of correctly stopping the ADRENAL trial for efficacy (around 91%), whereas the Haybittle-Peto approach achieved the greatest power for the NICE-SUGAR trial. Treatment effect estimates became increasingly underestimated as the number of interims increased.
CONCLUSIONS
This study confirms the right adaptive design can reach the same conclusion as a fixed design with a much-reduced sample size. The efficiency gain associated with an increased number of interims is highly relevant to late-phase critical care trials with large sample sizes and short follow-up times. Systematically exploring adaptive methods at the trial design stage will aid the choice of the most appropriate method.
Topics: Humans; Bayes Theorem; COVID-19; Critical Care; Research Design; Retrospective Studies; Sample Size; Clinical Trials as Topic
PubMed: 37853343
DOI: 10.1186/s12874-023-02049-6 -
World Journal of Gastrointestinal... Nov 2023Perforations (Perf) during endoscopic retrograde cholangiopancreatography (ERCP) are rare (< 1%) but potentially fatal events (up to 20% mortality). Given its rarity,...
BACKGROUND
Perforations (Perf) during endoscopic retrograde cholangiopancreatography (ERCP) are rare (< 1%) but potentially fatal events (up to 20% mortality). Given its rarity, most data is through case series studies from centers or analysis of large databases. Although a meta-analysis has shown fewer adverse events as a composite (bleeding, pancreatitis, Perf) during ERCP performed at high-volume centers, there is very little real-world data on endoscopist and center procedural volumes, ERCP duration and complexity on the occurrence of Perf.
AIM
To study the profile of Perf related to ERCP by center and endoscopist procedure volume, ERCP time, and complexity from a national endoscopic repository.
METHODS
Patients from clinical outcomes research initiative-national endoscopic database (2000-2012) who underwent ERCP were stratified based on the endoscopist and center volume (quartiles), and total procedure duration and complexity grade of the ERCP based on procedure details. The effects of these variables on the Perf that occurred were studied. Continuous variables were compared between Perf and no perforations (NoPerf) using the Mann-Whitney U test as the data demonstrated significant skewness and kurtosis.
RESULTS
A total of 14153 ERCPs were performed by 258 endoscopists, with 20 reported Perf (0.14%) among 16 endoscopists. Mean patient age in years 61.6 ± 14.8 58.1 ± 18.8 (Perf . NoPerf, = NS). The cannulation rate was 100% and 91.5% for Perf and NoPerf groups, respectively. 13/20 (65%) of endoscopists were high-volume performers in the 4 quartile, and 11/20 (55%) of Perf occurred in centers with the highest volumes (4 quartile). Total procedure duration in minutes was 60.1 ± 29.9 40.33 ± 23.5 (Perf NoPerf, < 0.001). Fluoroscopy duration in minutes was 3.3 ± 2.3 3.3 ± 2.6 (Perf NoPerf = NS). 50% of the procedures were complex and greater than grade 1 difficulty. 3/20 (15%) patients had prior biliary surgery. 13/20 (65%) had sphincterotomies performed with stent insertion. Peritonitis occurred in only 1/20 (0.5%).
CONCLUSION
Overall adverse events as a composite during ERCP are known to occur at a lower rate with higher volume endoscopists and centers. However, Perf studied from the national database show prolonged and more complex procedures performed by high-volume endoscopists at high-volume centers contribute to Perf.
PubMed: 38073762
DOI: 10.4253/wjge.v15.i11.641 -
Hospital Pediatrics Dec 2023Performance of minor procedures is highly variable among pediatric hospitalists. Our objective was to describe procedural frequency and measure self-assessed competence...
BACKGROUND AND OBJECTIVES
Performance of minor procedures is highly variable among pediatric hospitalists. Our objective was to describe procedural frequency and measure self-assessed competence in recommended minor procedures among practicing hospitalists.
METHODS
An electronic survey was administered across 20 US institutions. An individual survey assessed training, frequency, independence, and success in performing 11 minor procedures. The site survey described practice settings at participating study sites. The primary outcome was respondents' self-assessed competence (SAC), derived by averaging self-assessed independence and success scores (each on a 5-point Likert scale) across all 11 minor procedures. Associations between predictor variables and SAC were determined through analysis of variance for categorical variables and fitted regression models for continuous variables.
RESULTS
Of the 360 survey respondents, the majority were female (70%), not fellowship trained (78%), and had 10 years or fewer experience as a hospitalist (72%). Lumbar puncture and bag mask ventilation were most frequently performed. Greater procedural frequency and time since graduation from training were associated with higher SAC scores among respondents. Practice characteristics, including comanagement of patients and reserved time for practicing procedures, were associated with higher SAC scores. The presence of a simulation center and fellowship program was not associated with higher SAC scores.
CONCLUSIONS
Pediatric hospitalists that performed procedures more frequently had higher self-assessed procedural competence. Tailored opportunities with increased hands-on experience in performing minor procedures may be important to develop and maintain procedural skills.
Topics: Humans; Male; Female; Child; Hospitalists; Surveys and Questionnaires; Spinal Puncture; Fellowships and Scholarships
PubMed: 37927058
DOI: 10.1542/hpeds.2023-007202 -
Surgical Endoscopy Dec 2023The safe and effective performance of a robotic roux-en-y gastric bypass (RRNY) requires the application of a complex body of knowledge and skills. This qualitative...
BACKGROUND
The safe and effective performance of a robotic roux-en-y gastric bypass (RRNY) requires the application of a complex body of knowledge and skills. This qualitative study aims to: (1) define the tasks, subtasks, decision points, and pitfalls in a RRNY; (2) create a framework upon which training and objective evaluation of a RRNY can be based.
METHODS
Hierarchical and cognitive task analyses for a RRNY were performed using semi-structured interviews of expert bariatric surgeons to describe the thoughts and behaviors that exemplify optimal performance. Verbal data was recorded, transcribed verbatim, supplemented with literary and video resources, coded, and thematically analyzed.
RESULTS
A conceptual framework was synthesized based on three book chapters, three articles, eight online videos, nine field observations, and interviews of four subject matter experts (SME). At the time of the interview, SME had practiced a median of 12.5 years and had completed a median of 424 RRNY cases. They estimated the number of RRNY to achieve competence and expertise were 25 cases and 237.5 cases, respectively. After four rounds of inductive analysis, 83 subtasks, 75 potential errors, 60 technical tips, and 15 decision points were identified and categorized into eight major procedural steps (pre-procedure preparation, abdominal entry & port placement, gastric pouch creation, omega loop creation, gastrojejunal anastomosis, jejunojejunal anastomosis, closure of mesenteric defects, leak test & port closure). Nine cognitive behaviors were elucidated (respect for patient-specific factors, tactical modification, adherence to core surgical principles, task completion, judicious technique & instrument selection, visuospatial awareness, team-based communication, anticipation & forward planning, finessed tissue handling).
CONCLUSION
This study defines the key elements that formed the basis of a conceptual framework used by expert bariatric surgeons to perform the RRNY safely and effectively. This framework has the potential to serve as foundational tool for training novices.
Topics: Humans; Gastric Bypass; Robotic Surgical Procedures; Laparoscopy; Surgeons; Cognition; Obesity, Morbid; Anastomosis, Roux-en-Y
PubMed: 37702879
DOI: 10.1007/s00464-023-10354-w -
La Clinica Terapeutica 2023The present study aimed at determining the incidence of sternal foramina in adult dry bones of North Indian descent. We also aimed to determine the number, precise... (Observational Study)
Observational Study
OBJECTIVES
The present study aimed at determining the incidence of sternal foramina in adult dry bones of North Indian descent. We also aimed to determine the number, precise location of the sternal foramina with a standard reference point which might have considerable importance with regard to procedures involving sternal puncture.
METHODS
This cross sectional descriptive study was conducted on 72 dry adult human sternums. Various measurements in relation to the sternal foramina were taken with a non-stretchable measuring tape and digital vernier calliper and expressed as: [A]-total sternal length, [B]-distance between the jugular notches to the foramen, [C]-distance between the angle of Louis to the foramen and [D]-distance of the foramen from the mid sternal plane. Statistical analysis was performed with Microsoft Excel version 2019. A p-value of <0.05 was considered significant.
RESULTS
We found 6.94% (5 out of 72 sternums) incidence of sternal foramina which corroborates well with the existing literature. Mean sternal length was 127.7 ± 09 mm. The mean distance of the foramina from suprasternal notch, sternal angle and from the median plane were 118.12 ± 0.3 mm, 116.7 mm and 2.4 mm respectively. Incidence of sternal foramina was almost similar to previously reported studies.
CONCLUSIONS
The precise knowledge about the expected location of sternal foramina is imperative to avoid intra-thoracic visceral injury during commonly performed acupuncture needle insertion and while doing bone marrow aspiration for diagnostic evaluation.
Topics: Adult; Humans; Clinical Relevance; Cross-Sectional Studies; Knowledge; Neck; Research Design
PubMed: 38048113
DOI: 10.7417/CT.2023.5017 -
Therapeutic Innovation & Regulatory... Nov 2023In evaluating treatment efficacy, there is an ongoing discussion about which endpoint is more efficient to represent the treatment effect. Absolute change (AC) is the...
BACKGROUND
In evaluating treatment efficacy, there is an ongoing discussion about which endpoint is more efficient to represent the treatment effect. Absolute change (AC) is the difference between before and after treatment, while relative change (RC) is the AC relative to the baseline value. Principal investigators sometimes support the credibility of relative change, but the FDA is more likely to support absolute change. Therefore, whether these two endpoints can be translated or combined is worth investigating in order to satisfy both parties.
METHODS
In this article, a motivating example is presented to show that the choice of endpoint will result in different conclusions. The compared relationship of AC and RC is discussed in terms of required sample size, power, and precision. A new type of responder endpoint that combines the concepts of AC and RC is proposed. The comparative relationship regarding sample size, power, and precision of the proposed responder endpoint and the original two endpoints are also investigated.
RESULTS
As a result, the performance of AC and RC is highly dependent on the choice of threshold that is often informed based on minimum clinically important difference or other clinical experience. Therefore, an absolute translation between them is hard to achieve. Inspired by the concept of responder analysis, three types of responder endpoints are proposed and discussed. The pattern of the third type of responder endpoint is having higher power, higher precision, and less required sample size in estimating the treatment effect compared to AC and RC within a range of thresholds. This advantage becomes more obvious when applying higher AC and RC thresholds and lower [Formula: see text] threshold.
CONCLUSION
The proposed endpoint incorporates the information from the AC and RC endpoints and could be another wise choice when designing clinical trials especially when there is no absolute preference between AC and RC.
Topics: Sample Size; Research Design; Treatment Outcome
PubMed: 37555886
DOI: 10.1007/s43441-023-00556-8