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Current Medical Research and Opinion Jul 2024To compare the safety and efficacy of centanafadine versus methylphenidate hydrochloride extended release (ER; Concerta) in adults with ADHD. In the absence of...
To compare the safety and efficacy of centanafadine versus methylphenidate hydrochloride extended release (ER; Concerta) in adults with ADHD. In the absence of head-to-head trials, anchored matching-adjusted indirect comparisons (MAIC) were used to compare rates of adverse events reported across trials and mean change from baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) score between centanafadine and methylphenidate hydrochloride ER. Pooled patient-level data from two centanafadine trials (NCT03605680, NCT03605836) and aggregate data from one published methylphenidate hydrochloride ER trial (NCT00937040) were used. Characteristics of individual patients from the centanafadine trials were matched to aggregate baseline characteristics from the methylphenidate hydrochloride ER trial using propensity score weighting. A sensitivity analysis assessed the robustness of the results to the capping of extreme weights (i.e., above the 99 percentile). Compared with methylphenidate hydrochloride ER, centanafadine was associated with significantly lower risk of dry mouth (risk difference [RD] in percentage points: -11.95), initial insomnia (-11.10), decreased appetite (-8.05), anxiety (-5.39), palpitations (-5.25), and feeling jittery (-4.73) though a significantly smaller reduction in AISRS score (4.16-point). In the sensitivity analysis, the safety results were consistent with the primary analysis but there was no significant difference in efficacy between centanafadine and methylphenidate hydrochloride ER. In this anchored MAIC, centanafadine had a better safety profile and possibly lower efficacy than methylphenidate hydrochloride ER. While the safety results were robust across analyses, there was no difference in efficacy between centanafadine and methylphenidate hydrochloride ER in the sensitivity analysis. Considering its favorable safety profile, centanafadine may be preferred among patients for whom treatment-related adverse events are a concern.
PubMed: 38958732
DOI: 10.1080/03007995.2024.2373883 -
Child's Nervous System : ChNS :... Jul 2024Cervicothoracic ventral-dorsal rhizotomy (VDR) is a potential treatment of medically refractory hypertonia in patients who are not candidates for intrathecal baclofen,...
PURPOSE
Cervicothoracic ventral-dorsal rhizotomy (VDR) is a potential treatment of medically refractory hypertonia in patients who are not candidates for intrathecal baclofen, particularly in cases of severe upper limb hypertonia with limited to no function. A longitudinal cohort was identified to highlight our institutional safety and efficacy using cervicothoracic VDR for the treatment of hypertonia.
METHODS
Retrospective data analysis was performed for patients that underwent non-selective cervicothoracic VDR between 2022 and 2023. Non-modifiable risk factors, clinical variables, and operative characteristics were collected.
RESULTS
Six patients (three female) were included. Four patients underwent a bilateral C6-T1 VDR, one patient underwent a left C7-T1 VDR, and another underwent a left C6-T1 VDR. Three patients had quadriplegic mixed hypertonia, one patient had quadriplegic spasticity, one patient had triplegic mixed hypertonia, and one patient had mixed hemiplegic hypertonia. The mean difference of proximal upper extremity modified Ashworth scale (mAS) was - 1.4 ± 0.55 (p = 0.002), and - 2.2 ± 0.45 (p < 0.001) for the distal upper extremity. Both patients with independence noted quality of life improvements as well as increased ease with dressing and orthotics fits. Caregivers for the remaining four patients noted improvements in caregiving provision, mainly in dressing, orthotics fit, and ease when transferring.
CONCLUSION
Cervicothoracic VDR is safe and provides tone control and quality of life improvements in short-term follow-up. It can be considered for the treatment of refractory hypertonia. Larger multicenter studies with longer follow-up are necessary to further determine safety along with long-term functional benefits in these patients.
PubMed: 38958730
DOI: 10.1007/s00381-024-06479-5 -
International Urogynecology Journal Jul 2024Risk factors for pelvic floor disorders (PFDs) are not well understood in lower resource settings. The objective of this study is to determine the risk factors...
INTRODUCTION AND HYPOTHESIS
Risk factors for pelvic floor disorders (PFDs) are not well understood in lower resource settings. The objective of this study is to determine the risk factors associated with stress urinary incontinence (SUI), urge urinary incontinence (UUI), and pelvic organ prolapse (POP) among women of reproductive age in rural Nepal.
METHODS
This is a case-control study nested within a community-based cross-sectional survey of parous women of reproductive age with PFDs in the Sarlahi District of Nepal. The presence of PFDs was confirmed by clinical assessment. Detailed sociodemographic information and histories were captured.
RESULTS
We examined 406 women; the mean (SD, range) age was 32.7 (8.5, 16-49) years, mean BMI (SD) was 19.7 (3.3) kg/m, and median (range) number of pregnancies was 4 (1-11). Two hundred and three women (50.0%) had either SUI or UUI, 85 (17.8%) had both SUI and UUI, and 71 (17.5%) had POP at or beyond the hymen. After controlling for other variables significant on bivariate analysis, age (adjusted odds ratio [aOR] 1.06 [95% CI 1.03-1.09]), illiteracy (aOR 2.24 [95% CI 1.04-4.80]), and presence of upper gastrointestinal issues (aOR 3.30, [95% CI 1.77-6.16]) were independently associated with SUI/UUI. Age (aOR 1.05 [95% CI 1.02-1.09]), bispinous diameter (aOR 2.88 ([95% CI 1.11-7.47]), and subpubic angle (aOR 2.78 [95% CI 1.55-5.03]) were independently associated with POP.
CONCLUSION
Risk factors for PFDs in a homogenous community of parous women of reproductive age in rural Nepal are similar to those found in parous women in higher income countries.
PubMed: 38958728
DOI: 10.1007/s00192-024-05843-y -
European Journal of Applied Physiology Jul 2024Cardiopulmonary exercise testing (CPET) is considered the gold standard for assessing cardiorespiratory fitness. To ensure consistent performance of each test, it is...
PURPOSE
Cardiopulmonary exercise testing (CPET) is considered the gold standard for assessing cardiorespiratory fitness. To ensure consistent performance of each test, it is necessary to adapt the power increase of the test protocol to the physical characteristics of each individual. This study aimed to use machine learning models to determine individualized ramp protocols based on non-exercise features. We hypothesized that machine learning models will predict peak oxygen uptake ( O) and peak power output (PPO) more accurately than conventional multiple linear regression (MLR).
METHODS
The cross-sectional study was conducted with 274 (♀168, ♂106) participants who performed CPET on a cycle ergometer. Machine learning models and multiple linear regression were used to predict O and PPO using non-exercise features. The accuracy of the models was compared using criteria such as root mean square error (RMSE). Shapley additive explanation (SHAP) was applied to determine the feature importance.
RESULTS
The most accurate machine learning model was the random forest (RMSE: 6.52 ml/kg/min [95% CI 5.21-8.17]) for O prediction and the gradient boosting regression (RMSE: 43watts [95% CI 35-52]) for PPO prediction. Compared to the MLR, the machine learning models reduced the RMSE by up to 28% and 22% for prediction of O and PPO, respectively. Furthermore, SHAP ranked body composition data such as skeletal muscle mass and extracellular water as the most impactful features.
CONCLUSION
Machine learning models predict O and PPO more accurately than MLR and can be used to individualize CPET protocols. Features that provide information about the participant's body composition contribute most to the improvement of these predictions.
TRIAL REGISTRATION NUMBER
DRKS00031401 (6 March 2023, retrospectively registered).
PubMed: 38958720
DOI: 10.1007/s00421-024-05543-x -
Surgical Endoscopy Jul 2024Laparoscopic pancreatoduodenectomy (LPD) is one of the most challenging operations and has a long learning curve. Artificial intelligence (AI) automated surgical phase...
BACKGROUND
Laparoscopic pancreatoduodenectomy (LPD) is one of the most challenging operations and has a long learning curve. Artificial intelligence (AI) automated surgical phase recognition in intraoperative videos has many potential applications in surgical education, helping shorten the learning curve, but no study has made this breakthrough in LPD. Herein, we aimed to build AI models to recognize the surgical phase in LPD and explore the performance characteristics of AI models.
METHODS
Among 69 LPD videos from a single surgical team, we used 42 in the building group to establish the models and used the remaining 27 videos in the analysis group to assess the models' performance characteristics. We annotated 13 surgical phases of LPD, including 4 key phases and 9 necessary phases. Two minimal invasive pancreatic surgeons annotated all the videos. We built two AI models for the key phase and necessary phase recognition, based on convolutional neural networks. The overall performance of the AI models was determined mainly by mean average precision (mAP).
RESULTS
Overall mAPs of the AI models in the test set of the building group were 89.7% and 84.7% for key phases and necessary phases, respectively. In the 27-video analysis group, overall mAPs were 86.8% and 71.2%, with maximum mAPs of 98.1% and 93.9%. We found commonalities between the error of model recognition and the differences of surgeon annotation, and the AI model exhibited bad performance in cases with anatomic variation or lesion involvement with adjacent organs.
CONCLUSIONS
AI automated surgical phase recognition can be achieved in LPD, with outstanding performance in selective cases. This breakthrough may be the first step toward AI- and video-based surgical education in more complex surgeries.
PubMed: 38958719
DOI: 10.1007/s00464-024-10916-6 -
Lung Jul 2024This study was performed to construct and validate a risk prediction model for non-invasive ventilation (NIV) failure after birth in premature infants with gestational...
OBJECTIVES
This study was performed to construct and validate a risk prediction model for non-invasive ventilation (NIV) failure after birth in premature infants with gestational age < 32 weeks.
METHODS
The data were derived from the multicenter retrospective study program - Jiangsu Provincial Neonatal Respiratory Failure Collaboration Network from Jan 2019 to Dec 2021. The subjects finally included were preterm infants using NIV after birth with gestational age less than 32 weeks and admission age within 72 h. After screening by inclusion and exclusion criteria, 1436 babies were subsequently recruited in the study, including 1235 infants in the successful NIV group and 201 infants in the failed NIV group.
RESULTS
(1) Gestational age, 5 min Apgar, Max FiO during NIV, and FiO fluctuation value during NIV were selected by univariate and multivariate analysis. (2) The area under the curve of the prediction model was 0.807 (95% CI: 0.767-0.847) in the training set and 0.825 (95% CI: 0.766-0.883) in the test set. The calibration curve showed good agreement between the predicted probability and the actual observed probability (Mean absolute error = 0.008 for the training set; Mean absolute error = 0.012 for the test set). Decision curve analysis showed good clinical validity of the risk model in the training and test cohorts.
CONCLUSION
This model performed well on dimensions of discrimination, calibration, and clinical validity. This model can serve as a useful tool for neonatologists to predict whether premature infants will experience NIV failure after birth.
PubMed: 38958717
DOI: 10.1007/s00408-024-00727-w -
European Radiology Jul 2024To clarify the association between a radiomics score (Rad-score) derived from T1-weighted signal intensity to T2-weighted signal intensity (T1-w/T2-w) ratio images and...
OBJECTIVES
To clarify the association between a radiomics score (Rad-score) derived from T1-weighted signal intensity to T2-weighted signal intensity (T1-w/T2-w) ratio images and the progression of motor symptoms in Parkinson's disease (PD).
MATERIALS AND METHODS
This retrospective study included patients with PD enrolled in the Parkinson's Progression Markers Initiative. The Movement Disorders Society-Unified Parkinson's Disease Rating Scale Part III score ≥ 33 and/or Hoehn and Yahr stage ≥ 3 indicated motor function decline. The Rad-score was constructed using radiomics features extracted from T1-w/T2-w ratio images. The Kaplan-Meier analysis and Cox regression analyses were used to assess the time differences in motor function decline between the high and low Rad-score groups.
RESULTS
A total of 171 patients with PD were divided into training (n = 101, mean age at baseline, 61.6 ± 9.3 years) and testing (n = 70, mean age at baseline, 61.6 ± 10 years). The patients in the high Rad-score group had a shorter time to motor function decline than those in the low Rad-score group in the training dataset (log-rank test, p < 0.001) and testing dataset (log-rank test, p < 0.001). The multivariate Cox regression using the Rad-score and clinical factors revealed a significant association between the Rad-score and motor function decline in the training dataset (HR = 2.368, 95%CI:1.423-3.943, p < 0.001) and testing dataset (HR = 2.931, 95%CI:1.472-5.837, p = 0.002).
CONCLUSION
Rad-scores based on radiomics features derived from T1-w/T2-w ratio images were associated with the progression of motor symptoms in PD.
CLINICAL RELEVANCE STATEMENT
The radiomics score derived from the T1-weighted/T2-weighted ratio images offers a predictive tool for assessing the progression of motor symptom in patients with PD.
KEY POINTS
Radiomics score derived from T1-weighted/T2-weighted ratio images is correlated with the motor symptoms of Parkinson's disease. A high radiomics score correlated with faster motor function decline in patients with Parkinson's disease. The proposed radiomics score offers predictive insight into the progression of motor symptoms of Parkinson's disease.
PubMed: 38958697
DOI: 10.1007/s00330-024-10886-2 -
European Radiology Jul 2024To assess radiopalmar ganglion cysts' (RPG) prevalence, morphology, and clinical significance in consecutive patients.
OBJECTIVES
To assess radiopalmar ganglion cysts' (RPG) prevalence, morphology, and clinical significance in consecutive patients.
MATERIALS AND METHODS
In this retrospective single-center study, two radiologists assessed the presence of RPG and morphologic features on wrist MRI. Radiopalmar complaints and scapholunate ligament (SLL) tears were evaluated.
RESULTS
A total of 1053 wrists in 909 patients (mean age 43.4 ± 15.5 years, 602 females) were evaluated. All 308 RPG (Group 1; 308 patients, 29.2%) originated from the palmar capsule; 49 were unilocular, 95 oligolocular, and 164 multilocular; 745 wrists had no RPG (Group 2; 601 patients). One hundred and twenty-six RPG showed internal debris. The mean diameter was 8.5 ± 5.6 mm (cranio-caudal) (1.0-32.9 mm), 8.0 ± 4.1 mm (medio-lateral) (1.0-31.9 mm), and 3.7 ± 2.3 mm (dorso-palmar) (0.4-16.0 mm). 168 RPG showed direct contact with the radial vascular bundle, 24 with the flexor carpi radialis tendon, and 123 with the flexor pollicis longus tendon. In Group 1, significantly more patients showed partial (82/308) [group 2: 45/745, p < 0.001] or complete SLL tears (22/308) [group 2: 20/745, p < 0.001]. Of the patients with RPG, 15.3% presented with radiopalmar complaints. Only the dorso-palmar RPG diameter was positively correlated with radiopalmar complaints (for readers 1 and 2: r = 0.66/0.61, p < 0.001, respectively), and the best dorso-palmar diameter cut-off value for the probability of having radiopalmar complaints was defined at 3 mm (area under the curve (AUC) 0.74). Other morphologic features were not eligible to discriminate symptomatic patients (AUC range 0.53-0.61).
CONCLUSION
This study found RPG in 29% of patients, most of them asymptomatic. However, a dorso-palmar cyst diameter > 3 mm may be clinically significant.
CLINICAL RELEVANCE STATEMENT
Radiopalmar ganglion cysts, observed in 29% of wrist MR examinations, are mostly asymptomatic, but those with a larger dorso-palmar diameter may be associated with radiopalmar complaints.
KEY POINTS
Radiopalmar ganglion cysts are found in 29% of patients undergoing wrist MRI. Most patients with evidence of radiopalmar ganglion cysts do not show radiopalmar symptoms (85%). A dorso-palmar cyst diameter > 3 mm may be associated with radiopalmar complaints.
PubMed: 38958696
DOI: 10.1007/s00330-024-10884-4 -
European Radiology Jul 2024To assess the diagnostic efficacy of an MRI protocol and patient preparation in detecting deep pelvic endometriosis (DPE).
OBJECTIVES
To assess the diagnostic efficacy of an MRI protocol and patient preparation in detecting deep pelvic endometriosis (DPE).
MATERIAL AND METHODS
The cohort is from the ENDOVALIRM database, a multicentric national retrospective study involving women who underwent MRI followed by pelvic surgery for endometriosis (reference standard). Two senior radiologists independently analyzed MRI findings using the deep pelvic endometriosis index (dPEI) to determine lesion locations. The study evaluated the impact of bowel preparation, vaginal and rectal opacification, MRI unit type (1.5-T or 3-T), additional sequences (thin slice T2W or 3DT2W), and gadolinium injection on reader performance for diagnosing DPE locations. Fisher's exact test assessed differences in diagnostic accuracy based on patient preparation and MRI parameters.
RESULTS
The final cohort comprised 571 women with a mean age of 33.3 years (± 6.6 SD). MRI with bowel preparation outperformed MRI without bowel preparation in identifying torus/uterosacral ligament (USL) locations (p < 0.0001) and rectosigmoid nodules (p = 0.01). MRI without vaginal opacification diagnosed 94.1% (301/320) of torus/USL locations, surpassing MR with vaginal opacification, which diagnosed 85% (221/260) (p < 0.001). No significant differences related to bowel preparation or vaginal opacification were observed for other DPE locations. Rectal opacification did not affect diagnostic accuracy in the overall population, except in patients without bowel preparation, where performance improved (p = 0.04). There were no differences in diagnostic accuracy regarding MRI unit type (1.5-T/3-T), presence of additional sequences, or gadolinium injection for any endometriotic locations.
CONCLUSION
Bowel preparation prior to MRI examination is preferable to rectal or vaginal opacification for diagnosing deep endometriosis pelvic lesions.
CLINICAL RELEVANCE STATEMENT
Accurate diagnosis and staging of DPE are essential for effective treatment planning. Bowel preparation should be prioritized over rectal or vaginal opacification in MRI protocols. Optimizing MRI protocols for diagnostic performance with appropriate opacification techniques will help diagnose deep endometriosis more accurately.
KEY POINTS
Evaluating deep endometriosis in collapsible organs such as the vagina and rectum is difficult. Bowel preparation and an absence of vaginal opacification were found to be diagnostically beneficial. Bowel preparation should be prioritized over rectal or vaginal opacification in MRI protocols.
PubMed: 38958695
DOI: 10.1007/s00330-024-10842-0 -
European Journal of Physical and... Jul 2024Injections of botulinum toxin type A (BoNT-A) are the first-line treatment for spastic muscle overactivity (MO). Some authors observed that BoNT-A injections lead to...
INTRODUCTION
Injections of botulinum toxin type A (BoNT-A) are the first-line treatment for spastic muscle overactivity (MO). Some authors observed that BoNT-A injections lead to changes in muscle structure and muscle elasticity that are probably not completely reversible. This possible effect is critical, as it could lead to negative impacts on the effectiveness of BoNT-A interventions. Our study aimed to evaluate the current literature regarding changes in muscle elasticity and structure after BoNT-A injection, by diagnostic imaging, in neurological populations with MO. Our second objective was to pool all articles published on this topic in order to provide a quantitative synthesis of the data.
EVIDENCE ACQUISITION
A systematic search was conducted between October 2021 and April 2023 using different databases in accordance with PRISMA guidelines. Two independent reviewers screened articles for inclusion, extracted data, and evaluated methodological quality of the studies. A meta-analysis was performed to compare muscle elasticity and structure before and after BoNT-A injections.
EVIDENCE SYNTHESIS
A sample of 34 studies was selected for qualitative review and 19 studies for quantitative review. Meta-analysis of pre-post studies demonstrated significant improvement with a medium effect size (standardized mean difference=0.74; 95% CI 0.46-1.02; P<0.001) of muscle elasticity assessed by ultrasound elastography (USE) 4 weeks after BoNT-A injection. No statistically significant difference was found for muscle thickness, pennation angle, and muscle echo-intensity assessed by magnetic resonance imaging and/or ultrasonography at short-term. On the other hand, normalized muscle volume decreased with a small effect size (standardized mean difference = -0.17; 95% CI -0.25 - -0.09; P<0.001) 6 months after BoNT-A injection.
CONCLUSIONS
Muscle elasticity measured by USE improves with a temporary effect at short-term following BoNT-A injections. Synthesis of studies that assesses muscle structure is hindered by methodological differences between studies. However, based on a small amount of data, normalized muscle volume seems to decrease at long-term after BoNT-A injections in children with CP suggesting that the timing of re-injection should be considered with caution in this population. Further work should focus on the long-term effect of repeated injections on muscle structure and elasticity in neurological populations.
PubMed: 38958691
DOI: 10.23736/S1973-9087.24.08029-8