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Neurology India 2018Parkinson's disease (PD) and dystonia are common indications for the deep brain stimulation (DBS) procedure. It is very important to be diligent about target...
Parkinson's disease (PD) and dystonia are common indications for the deep brain stimulation (DBS) procedure. It is very important to be diligent about target localization and execution of the procedure. The single most important predictor of a good postoperative outcome is proper patient selection. The various steps of performing DBS include taking a preoperative non - stereotactic MRI, stereotactic frame fixation, fusion of MRI with stereotactic CT scan images, planning of the target and trajectory, lead placement at target through the planned trajectory, implantation of pulse generator/ battery and programming of the implanted device. Utmost care and precision are required to execute the procedure, which decide the final outcome of the surgical procedure.
Topics: Deep Brain Stimulation; Dystonia; Electrodes, Implanted; Humans; Movement Disorders; Neurosurgical Procedures; Patient Selection; Postoperative Period; Treatment Outcome
PubMed: 29503334
DOI: 10.4103/0028-3886.226461 -
Statistical Methods in Medical Research Feb 2015Medical imaging serves many roles in patient care and the drug approval process, including assessing treatment response and guiding treatment decisions. These roles... (Review)
Review
Medical imaging serves many roles in patient care and the drug approval process, including assessing treatment response and guiding treatment decisions. These roles often involve a quantitative imaging biomarker, an objectively measured characteristic of the underlying anatomic structure or biochemical process derived from medical images. Before a quantitative imaging biomarker is accepted for use in such roles, the imaging procedure to acquire it must undergo evaluation of its technical performance, which entails assessment of performance metrics such as repeatability and reproducibility of the quantitative imaging biomarker. Ideally, this evaluation will involve quantitative summaries of results from multiple studies to overcome limitations due to the typically small sample sizes of technical performance studies and/or to include a broader range of clinical settings and patient populations. This paper is a review of meta-analysis procedures for such an evaluation, including identification of suitable studies, statistical methodology to evaluate and summarize the performance metrics, and complete and transparent reporting of the results. This review addresses challenges typical of meta-analyses of technical performance, particularly small study sizes, which often causes violations of assumptions underlying standard meta-analysis techniques. Alternative approaches to address these difficulties are also presented; simulation studies indicate that they outperform standard techniques when some studies are small. The meta-analysis procedures presented are also applied to actual [18F]-fluorodeoxyglucose positron emission tomography (FDG-PET) test-retest repeatability data for illustrative purposes.
Topics: Biomarkers; Diagnostic Imaging; Guidelines as Topic; Humans; Meta-Analysis as Topic; Reproducibility of Results; Research Design; Statistics as Topic
PubMed: 24872353
DOI: 10.1177/0962280214537394 -
PloS One 2021Identifying barriers and facilitators in HIV-indicator reporting contributes to strengthening HIV monitoring and evaluation efforts by acknowledging contributors to...
Identifying barriers and facilitators in HIV-indicator reporting contributes to strengthening HIV monitoring and evaluation efforts by acknowledging contributors to success, as well as identifying weaknesses within the system that require improvement. Nonetheless, there is paucity in identifying and comparing barriers and facilitators in HIV-indicator data reporting among facilities that perform well and those that perform poorly at meeting reporting completeness and timeliness requirements. Therefore, this study aims to use a qualitative approach in identifying and comparing the current state of barriers and facilitators in routine reporting of HIV-indicators by facilities performing well, and those performing poorly in meeting facility reporting completeness and timeliness requirements to District Health Information Software2 (DHIS2). A multiple qualitative case study design was employed. The criteria for case selection was based on performance in HIV-indicator facility reporting completeness and timeliness. Areas of interest revolved around reporting procedures, organizational, behavioral, and technical factors. Purposive sampling was used to identify key informants in the study. Data was collected using semi-structured in-depth interviews with 13 participants, and included archival records on facility reporting performance, looking into documentation, and informal direct observation at 13 facilities in Kenya. Findings revealed that facilitators and barriers in reporting emerged from the following factors: interrelationship between workload, teamwork and skilled personnel, role of an EMRs system in reporting, time constraints, availability and access-rights to DHIS2, complexity of reports, staff rotation, availability of trainings and mentorship, motivation, availability of standard operating procedures and resources. There was less variation in barriers and facilitators faced by facilities performing well and those performing poorly. Continuous evaluations have been advocated within health information systems literature. Therefore, continuous qualitative assessments are also necessary in order to determine improvements and recurring of similar issues. These assessments have also complemented other quantitative analyses related to this study.
Topics: Electronic Health Records; HIV Infections; Health Facilities; Health Information Systems; Humans; Kenya; Qualitative Research; Research Design
PubMed: 33630971
DOI: 10.1371/journal.pone.0247525 -
Face and construct validity of TU-Delft epidural simulator and the value of real-time visualization.Regional Anesthesia and Pain Medicine Mar 2019Learning epidural anesthesia traditionally involves bedside teaching. Visualization aids or a simulator can help in acquiring motor skills, increasing patient safety and...
BACKGROUND AND OBJECTIVES
Learning epidural anesthesia traditionally involves bedside teaching. Visualization aids or a simulator can help in acquiring motor skills, increasing patient safety and steepening the learning curve. We evaluated the face and construct validity of the TU-Delft Epidural Simulator and the effect of needle visualization.
METHODS
Sixty-eight anesthesiologists, anesthesia residents, and final-year medical students tested the epidural simulator. Participants performed six epidural simulations with and six without needle visualization. We tested face validity on a Likert scale questionnaire. We collected data with the simulator software (spinal taps, dura contacts, bone contacts, attempts, and time) and tested for correlation with the performer's experience (construct validity). A visualization aid was tested in a randomized crossover design.
RESULTS
Face validity as rated by the participants was above average, with a mean of 3.7 (2.0-4.8) on a 5-point scale. Construct validity was indicated by significantly more spinal taps (0.4 [0-4) vs 0.07 [0-2], p=0.04) and more dura contacts (0.58 [0-6] vs 0.37 [0-3], p=0.002) by the inexperienced group compared with the expert group. The visualization aid improved performance by reducing the number of bone contacts and the number of attempts, and by decreasing the procedure time. Prior visualization training reduced the total procedure time from 279 s (69-574) to 180 s (53-605) (p0.01) for the "blind" procedure.
CONCLUSIONS
The TU-Delft Epidural Simulator is a useful tool for teaching motor skills during epidural needle placement. Prior use of a visualization tool improves performance even without visual support during consequent simulations.
PubMed: 30674695
DOI: 10.1136/rapm-2018-100161 -
Computer Methods and Programs in... Jul 2018Stroke is a cerebral artery disease that may lead to long-term disabilities or death. Patients that survive a stroke usually suffer balance impairments, which affect...
BACKGROUND
Stroke is a cerebral artery disease that may lead to long-term disabilities or death. Patients that survive a stroke usually suffer balance impairments, which affect their performance in activities of daily living (ADLs) and quality of life (QoL). In recent years, smartphones have become very popular and have many capabilities. Smartphone built-in sensors have shown their ability and potential in balance performance assessment. However, the feasibility of smartphones on subjects with chronic strokes remains to be proved. Therefore, the purpose of this study is to evaluate the feasibility of a smartphone-based balance assessment system for subjects with chronic stroke.
METHODS
Ten subjects with chronic stroke and thirteen healthy adults were recruited in the study. The smartphone HTC 10 (HTC Corporation, Taiwan) was used to perform the balance assessment, and its built-in accelerometer and gyroscope were used to record data from the subjects. Six postures were tested for thirty seconds each: shoulder-width stance (SWS) with eyes opened (E/O) and eyes closed (E/C), feet-together stance (FTS) with E/O and E/C, and semi-tandem stance (STS) with E/O and E/C. The smartphone was fixed to the back of subjects at the second sacral spine (S2) level. The changes registered in the accelerometer and gyroscope data were used to represent the balance performance, in which higher values indicate more instability. Data was analyzed using the independent t-test with the software SPSS 20, and the statistical significance level was set to α < 0.05.
RESULTS AND DISCUSSION
Significant difference in the acceleration data was found among subjects with chronic stroke and healthy adults under four assessment postures: SWS with E/C (p = 0.048), FTS with E/O (p = 0.027), FTS with E/C (p = 0.000), and STS with E/C (p = 0.048). Furthermore, according to the gyroscope data, there were significant differences in how the two groups performed the postures. The results demonstrate that a smartphone with a built-in accelerometer and gyroscope can be used to classify balance performances between healthy adults and subjects with chronic stroke.
CONCLUSION
This study shows that smartphones are feasible to assess balance for subjects with chronic stroke.
Topics: Acceleration; Activities of Daily Living; Adult; Aged; Chronic Disease; Female; Healthy Volunteers; Humans; Male; Middle Aged; Monitoring, Ambulatory; Paresis; Postural Balance; Quality of Life; Research Design; Sample Size; Smartphone; Software; Stroke
PubMed: 29852961
DOI: 10.1016/j.cmpb.2018.04.027 -
The Annals of Thoracic Surgery Mar 2022Whether robotic segmentectomies are advantageous is unclear. We describe our experience with the robot, comparing patient populations and outcomes with video-assisted...
BACKGROUND
Whether robotic segmentectomies are advantageous is unclear. We describe our experience with the robot, comparing patient populations and outcomes with video-assisted thoracoscopic surgery (VATS) and open resection.
METHODS
Patients who underwent anatomic segmentectomy from 2004 to 2019 were reviewed. Resection methods were categorized as robotic, VATS, or open. Segmentectomies were categorized as simple or complex. Baseline characteristics and perioperative outcomes were analyzed from 2015 to 2019 due to implementation of the Enhanced Recovery After Surgery pathway for all thoracic surgery patients and to thus minimize confounders resulting from the Enhanced Recovery After Surgery protocol.
RESULTS
Since 2004, an increase has occurred in segmentectomies, including robotic and complex segmentectomies. Of the 222 segmentectomies performed from 2015 to 2019, 77 (35%) were robotic, 40 VATS (18%), and 105 open (47%). More complex segmentectomies were performed in the robotic group compared with VATS and open (45% vs 15% vs 22%; P < .001). Operative time for robotic resections were longer compared with VATS and open (205 vs 147 vs 147 minutes; P < .001) but had lower blood loss (50 vs 75 vs 100 mL; P < .001) and shorter chest tube days (2 vs 2 vs 3 days; P = .004) and lengths of stay (3 vs 3 vs 4 days; P < .001). Perioperative mortality was low in all groups. No robotic segmentectomy was converted to open compared with 7.5% for VATS (P = .038). Prolonged air leak was lower for robotic compared with open (4% vs 13%; P = .038).
CONCLUSIONS
Robotic segmentectomy has increased in our institution, with a concurrent rise in atypical segmentectomies. Despite performing more complex procedures, there were no conversions and low perioperative morbidity and mortality. Our results suggest that the robotic platform can facilitate performance of complex anatomic segmentectomies.
Topics: Humans; Lung Neoplasms; Mastectomy, Segmental; Patient Selection; Pneumonectomy; Retrospective Studies; Robotic Surgical Procedures; Thoracic Surgery, Video-Assisted
PubMed: 33838123
DOI: 10.1016/j.athoracsur.2021.03.068 -
BMC Medical Research Methodology Nov 2022Diagnostic evidence of the accuracy of a test for identifying a target condition of interest can be estimated using systematic approaches following standardized...
BACKGROUND
Diagnostic evidence of the accuracy of a test for identifying a target condition of interest can be estimated using systematic approaches following standardized methodologies. Statistical methods for the meta-analysis of diagnostic test accuracy (DTA) studies are relatively complex, presenting a challenge for reviewers without extensive statistical expertise. In 2006, we developed Meta-DiSc, a free user-friendly software to perform test accuracy meta-analysis. This statistical program is now widely used for performing DTA meta-analyses. We aimed to build a new version of the Meta-DiSc software to include statistical methods based on hierarchical models and an enhanced web-based interface to improve user experience.
RESULTS
In this article, we present the updated version, Meta-DiSc 2.0, a web-based application developed using the R Shiny package. This new version implements recommended state-of-the-art statistical models to overcome the limitations of the statistical approaches included in the previous version. Meta-DiSc 2.0 performs statistical analyses of DTA reviews using a bivariate random effects model. The application offers a thorough analysis of heterogeneity, calculating logit variance estimates of sensitivity and specificity, the bivariate I-squared, the area of the 95% prediction ellipse, and the median odds ratios for sensitivity and specificity, and facilitating subgroup and meta-regression analyses. Furthermore, univariate random effects models can be applied to meta-analyses with few studies or with non-convergent bivariate models. The application interface has an intuitive design set out in four main menus: file upload; graphical description (forest and ROC plane plots); meta-analysis (pooling of sensitivity and specificity, estimation of likelihood ratios and diagnostic odds ratio, sROC curve); and summary of findings (impact of test through downstream consequences in a hypothetical population with a given prevalence). All computational algorithms have been validated in several real datasets by comparing results obtained with STATA/SAS and MetaDTA packages.
CONCLUSION
We have developed and validated an updated version of the Meta-DiSc software that is more accessible and statistically sound. The web application is freely available at www.metadisc.es .
Topics: Humans; Algorithms; Diagnostic Tests, Routine; Odds Ratio; Records; Software; Meta-Analysis as Topic
PubMed: 36443653
DOI: 10.1186/s12874-022-01788-2 -
Surgical Endoscopy Jun 2019Performing endoscopic retrograde cholangiopancreatography (ERCP) in patients with Roux-en-Y gastric bypass (RYGB) anatomy is technically challenging. Device-assisted...
BACKGROUND
Performing endoscopic retrograde cholangiopancreatography (ERCP) in patients with Roux-en-Y gastric bypass (RYGB) anatomy is technically challenging. Device-assisted enteroscopy and laparoscopic-assisted methods suffer from high failure rates and/or post-procedural complications. A novel endoscopic technique termed EUS-Directed Transgastric ERCP (EDGE) or Gastric Access Temporary for Endoscopy (GATE) has recently emerged, demonstrating excellent technical and therapeutic success. The technique involves endoscopic ultrasound-guided deployment of a lumen-apposing metal stent (LAMS) to gain access into the remnant stomach to facilitate standard ERCP. In this case series, we describe our center's experience and unique approach with the GATE procedure and discuss several key strategies and differences.
METHODS
Patients underwent the GATE procedure via a novel algorithmic approach. Key information on procedural details, technical and clinical success, follow-up, and adverse events was prospectively collected and retrospectively reviewed.
RESULTS
10 patients underwent the GATE procedure from May 2017 to March 2018. Technical and clinical success were both 100%. Gastric and jejunal access points for LAMS deployment were 30% and 70%, respectively. Total procedure time per patient, including LAMS deployment, ERCP, and all follow-up procedures, averaged 2.37 ± 0.63 h. 2 out of 10 patients (20%) had adverse events that were resolved either intra-procedurally or after repeat endoscopy with no long-term complications and none requiring surgery. For patients with complete follow-up (n = 7), access tract closure rate was 100% with the aid of a temporary plastic double pigtail stent to facilitate closure.
CONCLUSIONS
GATE appears to be a safe and effective procedure and may be considered the preferred approach to ERCP in patients with RYGB anatomy at centers with LAMS experience. The procedure offers more definitive and higher range of ERCP interventions compared to traditional methods and is associated with fewer adverse events. Improvements in strategies and methods with the GATE technique may reduce risks and improve outcomes.
Topics: Aged; Algorithms; Cholangiopancreatography, Endoscopic Retrograde; Endoscopy, Gastrointestinal; Female; Gastric Bypass; Humans; Male; Middle Aged; Retrospective Studies
PubMed: 30805786
DOI: 10.1007/s00464-019-06715-z -
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 -
Studies in Health Technology and... Aug 2022Certification of Medical Device Software (MDS) according to the EU Medical Device Regulation 2017/745 requires demonstrating safety and effectiveness. Thus, the syllabus...
Certification of Medical Device Software (MDS) according to the EU Medical Device Regulation 2017/745 requires demonstrating safety and effectiveness. Thus, the syllabus of a course on MDS development must provide tools for addressing these issues. To assure safety, risk analysis has to be performed using a four-step procedure. Effectiveness could be demonstrated by literature systematic review combined with meta-analysis, to compare the MDS performances with those of similar tools.
Topics: Certification; Humans; Medical Device Legislation; Meta-Analysis as Topic; Software; Systematic Reviews as Topic
PubMed: 36073476
DOI: 10.3233/SHTI220928