-
AEM Education and Training Apr 2020Emergency department thoracotomy (EDT) is a rare and challenging procedure. Emergency medicine (EM) residents have limited opportunities to perform the procedure in...
OBJECTIVES
Emergency department thoracotomy (EDT) is a rare and challenging procedure. Emergency medicine (EM) residents have limited opportunities to perform the procedure in clinical or educational settings. Standardized, reliable, validated checklists do not exist to evaluate procedural competency. The objectives of this project were twofold: 1) to develop a checklist containing the critical actions for performing an EDT that can be used for future procedural skills training and 2) to evaluate the reliability and validity of the checklist for performing EDT.
METHODS
After a literature review, a preliminary 22-item checklist was developed and disseminated to experts in EM and trauma surgery. A modified Delphi method was used to revise the checklist. To assess usability of the checklist, EM and trauma surgery faculty and residents were evaluated performing an EDT while inter-rater reliability was calculated with Cohen's kappa. A Student's t-test was used to compare the performance of participants who had or had not performed a thoracotomy in clinical practice. Item-total correlation was calculated for each checklist item to determine discriminatory ability.
RESULTS
A final 22-item checklist was developed for EDT. The overall inter-rater reliability was strong (κ = 0.84) with individual item agreement ranging from moderate to strong (κ = 0.61 to 1.00). Experts (attending physicians and senior residents) performed well on the checklist, achieving an average score of 80% on the checklist. Participants who had performed EDT in clinical practice performed significantly better than those that had not, achieving an average of 80.7% items completed versus 52.3% (p < 0.05). Seventeen of 22 items had an item-total correlation greater than 0.2.
CONCLUSIONS
A final 22-item consensus-based checklist was developed for the EDT. Overall inter-rater reliability was strong. This checklist can be used in future studies to serve as a foundation for curriculum development around this important procedure.
PubMed: 32313860
DOI: 10.1002/aet2.10387 -
BMJ Open Sep 2022Sacroiliac joint (SIJ) dysfunction has been shown to cause significant morbidity. Current treatment includes conservative management and surgical intervention....
INTRODUCTION
Sacroiliac joint (SIJ) dysfunction has been shown to cause significant morbidity. Current treatment includes conservative management and surgical intervention. Previously published data reporting clinical and surgical outcomes reached conflicting conclusions. This protocol aims to conduct a meta-analysis to determine fusion rates and patient-reported outcomes of minimally invasive (MIS) SIJ fusions compared with conservative treatment.
METHODS AND ANALYSIS
We drafted our protocol according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines. We will search PubMed, Embase and the Cochrane Library, supplemented by manual search when necessary. Two independent reviewers will screen for eligibility by title/abstract, then full text, arbitrated by a third reviewer if necessary. The two reviewers will carry out a risk of bias assessment using the Cochrane Collaboration Risk of Bias tool for randomised controlled trial and the Methodological Index for Non-Randomised Studies tool for observational cohort studies. A third reviewer will arbitrate any disagreement. We will perform data synthesis using Review Manager (RevMan for Windows, V.5.4.1, The Cochrane Collaboration, 2020) and Comprehensive Meta-Analysis (V.3.3.070). Meta-bias will be evaluated and confidence determined using the Grading of Recommendations, Assessment, Development and Evaluation guidelines.
ETHICS AND DISSEMINATION
Ethical approval for this review will not be required as no patient data is being collected. The results of this study will be submitted for publication in peer-reviewed journals.
PROSPERO REGISTRATION NUMBER
CRD42021273481.
Topics: Humans; Arthrodesis; Meta-Analysis as Topic; Minimally Invasive Surgical Procedures; Randomized Controlled Trials as Topic; Research Design; Sacroiliac Joint; Treatment Outcome
PubMed: 36691136
DOI: 10.1136/bmjopen-2021-056989 -
BMJ Open May 2024The realm of neurosurgery is currently witnessing a surge in primary research, underscoring the importance of adopting evidence-based approaches. Scoping reviews, as a...
INTRODUCTION
The realm of neurosurgery is currently witnessing a surge in primary research, underscoring the importance of adopting evidence-based approaches. Scoping reviews, as a type of evidence synthesis, offer a broad perspective and have become increasingly vital for managing the ever-expanding body of research in swiftly evolving fields. Recent research has indicated a rising prevalence of scoping reviews in healthcare literature. In this context, the concept of a 'review of scoping reviews' has emerged as a means to offer a higher level synthesis of insights. However, the field of neurosurgery appears to lack a comprehensive integration of scoping reviews. Therefore, the objective of this scoping review is to identify and evaluate the extent of scoping reviews within neurosurgery, pinpointing research gaps and methodological issues to enhance evidence-based practices in this dynamic discipline.
METHODS
The method framework of Arksey and O'Malley will be used to conduct the scoping review. A thorough literature search will be performed on Medline, Scopus and Web of Science to find eligible studies using the keywords related to , . Two reviewers will independently revise all of the full-text articles, extract data and evaluate the study extent. A narrative overview of the findings from included studies will be given.
ETHICS AND DISSEMINATION
This review will involve secondary analysis of published literature, and therefore ethics approval is not required. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist will be used to guide translation of findings. Results will be disseminated through peer-reviewed journals and presented in conferences via abstract and presentation.
Topics: Humans; Neurosurgery; Review Literature as Topic; Research Design; Systematic Reviews as Topic; Neurosurgical Procedures
PubMed: 38719324
DOI: 10.1136/bmjopen-2023-080878 -
PharmacoEconomics Jan 2022Time-to-event data from clinical trials are routinely extrapolated using parametric models to estimate the cost effectiveness of novel therapies, but how this approach...
INTRODUCTION
Time-to-event data from clinical trials are routinely extrapolated using parametric models to estimate the cost effectiveness of novel therapies, but how this approach performs in the presence of heterogeneous populations remains unknown.
METHODS
We performed a simulation study of seven scenarios with varying exponential distributions modelling treatment and prognostic effects across subgroup and complement populations, with follow-up typical of clinical trials used to appraise the cost effectiveness of therapies by agencies such as the UK National Institute for Health and Care Excellence (NICE). We compared established and emerging methods of estimating population life-years (LYs) using parametric models. We also proved analytically that an exponential model fitted to censored heterogeneous survival times sampled from two distinct exponential distributions will produce a biased estimate of the hazard rate and LYs.
RESULTS
LYs are underestimated by the methods in the presence of heterogeneity, resulting in either under- or overestimation of the incremental benefit. In scenarios where the overestimation of benefit is likely, which is of interest to the healthcare provider, the method of taking the average LYs from all plausible models has the least bias. LY estimates from complete Kaplan-Meier curves have high variation, suggesting mature data may not be a reliable solution. We explore the effect of increasing trial sample size and accounting for detected treatment-subgroup interactions.
CONCLUSIONS
The bias associated with heterogeneous populations suggests that NICE may need to be more cautious when appraising therapies and to consider model averaging or the separate modelling of subgroups when heterogeneity is suspected or detected.
Topics: Bias; Biomedical Technology; Computer Simulation; Cost-Benefit Analysis; Humans; Sample Size
PubMed: 34580839
DOI: 10.1007/s40273-021-01082-x -
PloS One 2023This study proposes a robust outlier detection method based on the circular median for non-parametric linear-circular regression in case the response variable includes...
This study proposes a robust outlier detection method based on the circular median for non-parametric linear-circular regression in case the response variable includes outlier(s) and the residuals are Wrapped-Cauchy distributed. Nadaraya-Watson and local linear regression methods were employed to obtain non-parametric regression fits. The proposed method's performance was investigated by using a real dataset and a comprehensive simulation study with different sample sizes, contamination, and heterogeneity degrees. The method performs quite well in medium and higher contamination degrees, and its performance increases as the sample size and the homogeneity of data increase. In addition, when the response variable of linear-circular regression contains outliers, the Local Linear Estimation method fits the data set better than the Nadaraya Watson method.
Topics: Humans; Linear Models; Computer Simulation; Drug Contamination; Sample Size; Seizures
PubMed: 37307265
DOI: 10.1371/journal.pone.0286448 -
JAMA Otolaryngology-- Head & Neck... Mar 2020Chronic rhinosinusitis is among the most common and costly conditions treated by physicians. After failure of medical treatment, surgical intervention in the form of...
IMPORTANCE
Chronic rhinosinusitis is among the most common and costly conditions treated by physicians. After failure of medical treatment, surgical intervention in the form of endoscopic sinus surgery is traditionally offered. Balloon catheter dilation (BCD) has become a less-invasive alternative with increasing popularity among otolaryngologists.
OBJECTIVE
To evaluate the most recent BCD data in the Medicare population, with a specific focus on the percentage of procedures performed by surgeons who perform high volumes of this procedure, their reimbursements, and their national geographic distributions.
DESIGN, SETTING, AND PARTICIPANTS
This retrospective review included data from 2011 through 2017 from Medicare Part B National Summary Data Files and Medicare Provider Utilization and Payment Data. Patients with procedures including Current Procedural Terminology codes 31295 (maxillary sinus dilation), 31296 (frontal sinus dilation), and 31297 (sphenoid sinus dilation) were included.
EXPOSURES
Balloon catheter dilation of the paranasal sinuses.
MAIN OUTCOMES AND MEASURES
Total and mean reimbursements over time to physicians for BCDs, as well as the percentage of BCDs performed by and reimbursed to ear, nose, and throat (ENT) surgeons who perform high volumes of BCDs (>10 procedures) in a given year.
RESULTS
The total number of BCDs rose from 7496 in 2011 to 43 936 in 2017 (a 486% increase). The overall reimbursement increased from $11 773 049 in 2011 to $63 927 591 in 2017 (a 433% increase). From 2012 to 2016, ENT surgeons who performed high volumes of the procedures rose from 101 to 382 surgeons (a 270% increase). In 2016, 25 214 of 41 960 BCDs (60.1%) were performed by ENT surgeons performing high volumes of the procedure, compared with 5603 of 13 109 procedures (42.7%) in 2012. In a line of best fit, at the 75th percentile of procedure volume, there was an increase of 4.2 BCDs in the median number of procedures done per physician per year, compared with an increase of 1.5 BCD procedures per physician per year in the line of best fit for the 50th percentile.
CONCLUSIONS AND RELEVANCE
Balloon catheter dilation continues to increase in popularity among otolaryngologists treating chronic rhinosinusitis. Most BCDs are performed by ENT surgeons who perform high volumes of the procedure.
Topics: Aged; Catheterization; Chronic Disease; Dilatation; Female; Humans; Insurance, Health, Reimbursement; Male; Medicare; Procedures and Techniques Utilization; Retrospective Studies; Rhinitis; Sinusitis; United States
PubMed: 31971549
DOI: 10.1001/jamaoto.2019.4357 -
Methods of Information in Medicine Jun 2022Receiver operating characteristic (ROC) analysis is commonly used for comparing models and humans; however, the exact analytical techniques vary and some are flawed. (Review)
Review
BACKGROUND
Receiver operating characteristic (ROC) analysis is commonly used for comparing models and humans; however, the exact analytical techniques vary and some are flawed.
OBJECTIVES
The aim of the study is to identify common flaws in ROC analysis for human versus model performance, and address them.
METHODS
We review current use and identify common errors. We also review the ROC analysis literature for more appropriate techniques.
RESULTS
We identify concerns in three techniques: (1) using mean human sensitivity and specificity; (2) assuming humans can be approximated by ROCs; and (3) matching sensitivity and specificity. We identify a technique from Provost et al using dominance tables and cost-prevalence gradients that can be adapted to address these concerns.
CONCLUSION
Dominance tables and cost-prevalence gradients provide far greater detail when comparing performances of models and humans, and address common failings in other approaches. This should be the standard method for such analyses moving forward.
Topics: Humans; Prevalence; ROC Curve; Research Design; Sensitivity and Specificity
PubMed: 34972233
DOI: 10.1055/s-0041-1740565 -
Trials Oct 2022Failure to consider relevant cultural, ethnic and diversity parameters (and the intersection between these parameters) during trial protocol development and trial... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Failure to consider relevant cultural, ethnic and diversity parameters (and the intersection between these parameters) during trial protocol development and trial conduct may negatively impact recruitment, intervention development and delivery, and participant adherence and retention, potentially reducing overall internal validity. This case study aimed to evaluate the utility and comparability between the 9-item Gibbs Framework to measure cultural competency and the GRIPP-2(Short Form (SF)) 5-point checklist to assess patient and public involvement in the context of a complex clinical trial conducted in an African setting.
METHODS
We identified and collated all relevant publications, source and procedural data related to the trial and integrated the documents into a dynamic trial timeline. Two independent investigators applied and scored the Gibbs Framework and the GRIPP-2(SF) checklist to the four publications arising from the trial, noting functionality and comparability between tools. Where cultural competency was not met, a third investigator screened all procedural and source data and identified if cultural competency had been achieved but not reported in the publications, or if the trial had not met appropriate cultural competency based on the documentation.
RESULTS
Application of the Gibbs Framework found that the trial scored '2' for seven of the nine Gibbs items, indicating full cultural competency for those questions. The Framework indicated that the trial research question was not driven by the articulated needs of patients, and neither were patients, caregivers and clinical providers involved in the development of the intervention. Comparability with the GRIPP-2(SF) checklist showed that the Gibbs performed better on evaluation of partnerships with the community, identification of culturally competent data sources and target populations, and appointment of trial staff in an inclusive manner.
CONCLUSIONS
Comprehensive evaluation of the trial's cultural competency required scrutiny of both published manuscripts and source and procedural data, suggesting that there is a gap in current trial reporting standards with respect to cultural competence.
TRIAL REGISTRATION
PACTR201610001825403. Registered on 17 October 2016.
Topics: Humans; Cultural Competency; South Africa; Checklist; Research Design
PubMed: 36309756
DOI: 10.1186/s13063-022-06767-y -
CPT: Pharmacometrics & Systems... Feb 2022The success of correctly identifying all the components of a nonlinear mixed-effects model is far from straightforward: it is a question of finding the best structural...
The success of correctly identifying all the components of a nonlinear mixed-effects model is far from straightforward: it is a question of finding the best structural model, determining the type of relationship between covariates and individual parameters, detecting possible correlations between random effects, or also modeling residual errors. We present the Stochastic Approximation for Model Building Algorithm (SAMBA) procedure and show how this algorithm can be used to speed up this process of model building by identifying at each step how best to improve some of the model components. The principle of this algorithm basically consists in "learning something" about the "best model," even when a "poor model" is used to fit the data. A comparison study of the SAMBA procedure with Stepwise Covariate Modeling (SCM) and COnditional Sampling use for Stepwise Approach (COSSAC) show similar performances on several real data examples but with a much reduced computing time. This algorithm is now implemented in Monolix and in the R package Rsmlx.
Topics: Algorithms; Humans; Nonlinear Dynamics; Research Design
PubMed: 35104058
DOI: 10.1002/psp4.12742 -
Genes Feb 2023Outliers in the training or test set used to fit and evaluate a classifier on transcriptomics data can considerably change the estimated performance of the model. Hence,...
Outliers in the training or test set used to fit and evaluate a classifier on transcriptomics data can considerably change the estimated performance of the model. Hence, an either too weak or a too optimistic accuracy is then reported and the estimated model performance cannot be reproduced on independent data. It is then also doubtful whether a classifier qualifies for clinical usage. We estimate classifier performances in simulated gene expression data with artificial outliers and in two real-world datasets. As a new approach, we use two outlier detection methods within a bootstrap procedure to estimate the outlier probability for each sample and evaluate classifiers before and after outlier removal by means of cross-validation. We found that the removal of outliers changed the classification performance notably. For the most part, removing outliers improved the classification results. Taking into account the fact that there are various, sometimes unclear reasons for a sample to be an outlier, we strongly advocate to always report the performance of a transcriptomics classifier with and without outliers in training and test data. This provides a more diverse picture of a classifier's performance and prevents reporting models that later turn out to be not applicable for clinical diagnoses.
Topics: Transcriptome; Gene Expression Profiling; Probability; Research Design
PubMed: 36833313
DOI: 10.3390/genes14020387