Categories
Nevin Manimala Statistics

Evaluation of morphological features: femtosecond-LASIK flap vs. SMILE cap, and the effects on corneal higher-order aberrations

Graefes Arch Clin Exp Ophthalmol. 2022 Sep 27. doi: 10.1007/s00417-022-05841-0. Online ahead of print.

ABSTRACT

PURPOSE: The aim of this study is to evaluate morphological features of corneal flap/cap and the correlations with corneal higher-order aberrations (HOAs) changes after femtosecond laser in situ keratomileusis (FS-LASIK) and small incision lenticule extraction (SMILE).

METHODS: This was a retrospective study. Pre- and postoperative (1 and 3 months) corneal HOAs were assessed with Pentacam HR. The corneal flap/cap thickness at 32 points (± 1.5 mm, ± 2 mm, ± 2.5 mm, and ± 3 mm from the corneal vertex on meridian 0°/45°/90°/135°) were measured using anterior segment optical coherence tomography at 3 months postoperatively. Morphological features of corneal flap/cap including predictability (P), uniformity (U), and symmetry (S) were calculated and used for correlation analysis with corneal HOAs changes.

RESULTS: Eighty-six eyes (44 patients) and ninety-six eyes (50 patients) were involved in FS-LASIK and SMILE groups, respectively. Significant thicker corneal flap/cap than the predicted was observed at each measuring point and meridian in both groups (difference > 2.225 μm, the within-subject standard deviation over 6-mm optical zone). There was no statistically significant difference in predictability of corneal flap/cap thickness, while U6 mm (P < .0001), U0 (P < .001), U45 (P = .002), U90 (P < .0001), U135 (P = .004), S6 mm (P < .0001), S0 (P < .001), and S90 (P < .0001) over 6 mm zone were less in SMILE than in FS-LASIK. The changes of corneal tHOAs, Z (3, – 1), Z (3, 1), and SA were significantly correlated with morphological features of corneal flap/cap.

CONCLUSION: Both FS-LASIK and SMILE had good predictability in flap or cap thickness, while the uniformity and symmetry of SMILE cap were better than FS-LASIK flap. The quality of flap/cap was closely associated with the changes of corneal HOAs.

PMID:36166075 | DOI:10.1007/s00417-022-05841-0

Categories
Nevin Manimala Statistics

AED drones on the rise? : Use of drones to improve public access defibrillation

Anaesthesiologie. 2022 Sep 27. doi: 10.1007/s00101-022-01204-w. Online ahead of print.

ABSTRACT

BACKGROUND: The poor availability of automatic external defibrillators (AED) and the modest knowledge of lay persons in handling these devices has led to an insufficient spread of public access defibrillation in Germany.

OBJECTIVE: This article examines whether the automated deployment of AED drones to out-of-hospital cardiac arrest can help to remedy this situation.

METHODS: Narrative literature review, evaluation of statistics, analysis of relevant media reports, and discussion of key research.

RESULTS: The present investigations are mainly located in the experimental field and demonstrate the feasibility and safety of drone use, as well as shorter times to first defibrillation, which is confirmed by initial clinical studies. Mathematical models also indicate cost-effectiveness of airborne AED delivery compared to ground dispatch. Integration into the chain of survival appears to be possible but adaptations to existing emergency medical service structures and close cooperation with regional first responder and AED schemes as well as local authorities is required to optimise patient benefit and efficiency.

CONCLUSION: The use of AED drones could probably contribute to improving public access defibrillation in Germany. This applies to both rural and urban regions. The technological requirements are met but flight regulations still have to be amended. In order to explore the full potential of this novel technology, further field trials are required to achieve smooth integration into existing emergency medical services.

PMID:36166065 | DOI:10.1007/s00101-022-01204-w

Categories
Nevin Manimala Statistics

Potential effect of the stimulus threshold level of the nociceptive flexion reflex (NFRT) on mortality and delirium incidence in the critically ill patient: a retrospective cohort analysis

Anaesthesiologie. 2022 Sep 27. doi: 10.1007/s00101-022-01206-8. Online ahead of print.

ABSTRACT

BACKGROUND: Mortality and delirium in critically ill patients are affected by the provided analgesics and sedatives. The deeper the sedation and the higher the dose of analgesics applied, the more difficult it is to assess pain and the depth of sedation. Therefore, instrumental measurement methods, such as the measurement of the stimulus threshold of the nociceptive flexion reflex (NFRT), are becoming increasingly more important.

OBJECTIVE: The aim of the present study is to investigate a potential association between the level of the nociceptive flexion reflex, mortality, and the occurrence of delirium.

MATERIAL AND METHODS: By retrospectively analyzing a pilot data set of 57 ICU patients from the interdisciplinary surgical ICU of Ulm University Hospital surveyed between 11/2018 and 03/2020, a possible association between the NFRT, mortality, and the occurrence of delirium was calculated in an adjusted logistic regression model. Depending on the cut-off value, the stimulus threshold corridors result in the following comparison pairs: < 20 mA vs. 20-40 mA/20-50 mA/20-60 mA, > 40 mA vs. 20-40 mA, > 50 mA vs. 20-50 mA and > 60 mA vs. 20-60 mA. Results are presented as odds ratios (OR) adjusted for age, sex, height, TISS-28, SAPS II, RASS, BPS, and applied analgesics. Pain assessment was performed, in addition to the Behavioral Pain scale, ≥ 3 times daily by measuring NFRT.

RESULTS: A statistically nonsignificant tendency for an increase in mortality incidence occurred with an NFRT > 50 mA, versus a stimulus threshold corridor of 20-50 mA (OR 3.3, CI: 0.89-12.43, p = 0.07). A trend toward a reduction in delirium incidence occurred at an NFRT < 20 mA, versus a stimulus threshold corridor of 20-40 mA (OR 0.40, CI: 0.18-0.92, p = 0.03).

CONCLUSION: Based on the level of the NFRT, no recommendation can be made at this point to adjust the analgesic regimen of critically ill patients, who are unable to communicate. The observation of a tendency towards an increase in mortality at high stimulus thresholds or a reduction in the occurrence of delirium at low stimulus thresholds of the NFRT must be verified in standardized studies.

PMID:36166064 | DOI:10.1007/s00101-022-01206-8

Categories
Nevin Manimala Statistics

The PSR13, a tool for evaluating patient-perceived recovery after vaginal prolapse repair surgery

Int Urogynecol J. 2022 Sep 27. doi: 10.1007/s00192-022-05372-6. Online ahead of print.

ABSTRACT

INTRODUCTION AND HYPOTHESIS: Surgical recovery is the return to preoperative functional, psychologic, and social activity, or a return to normalcy. To date, little is known about the global post-surgical recovery experience from the patients’ perspective. The aim of this study was to validate the Post-Discharge Surgical Recovery scale 13 (PSR13) in women undergoing vaginal prolapse repair procedures and evaluate the patient-perceived postoperative recovery experience over a 12-week period.

METHODS: Fifty women undergoing vaginal prolapse repairs completed the PSR13 and global surgical recovery scale (GSR) at 1, 2, 4, 6, and 12 weeks post-surgery. Validity, the minimal clinically important difference (MCID), and responsiveness to change over time of the PSR13 was evaluated using descriptive statistics and linear regression models. The proportion of patients deemed fully recovered at each time point (defined as PSR13 score ≥ 80) was also assessed.

RESULTS: The PSR13 correlated significantly (p < 0.001) with the single-item recovery scale and showed excellent internal consistency reliability (Cronbach α = 0.91, range 0.77 to 0.93). The MCID was estimated at 7.0 points. The PSR13 scores improved at varying rates over time, with the greatest amount of patient-perceived recovery occurring between 4 and 6 weeks after surgery. The proportion of patients deemed fully recovered at 6- and 12- weeks postoperatively was 37% and 56%, respectively.

CONCLUSIONS: The PSR13 is a useful instrument to assess overall return to normalcy from the patient’s perspective and can be applied to evaluate the recovery experience among women undergoing vaginal prolapse repairs, in both the research and clinical setting.

PMID:36166063 | DOI:10.1007/s00192-022-05372-6

Categories
Nevin Manimala Statistics

Effect of Robot-Assisted Radical Cystectomy vs Open Radical Cystectomy on 90-Day Morbidity and Mortality Among Patients With Bladder Cancer-Reply

JAMA. 2022 Sep 27;328(12):1258-1259. doi: 10.1001/jama.2022.13600.

NO ABSTRACT

PMID:36166034 | DOI:10.1001/jama.2022.13600

Categories
Nevin Manimala Statistics

Clinical pharmacology information in regulatory submissions and labeling: A comparative analysis of orphan and non-orphan drugs approved by the FDA

Clin Transl Sci. 2022 Sep 27. doi: 10.1111/cts.13362. Online ahead of print.

ABSTRACT

Clinical pharmacology is an integral discipline supporting the development, regulatory evaluation, and clinical use of drugs for the treatment of both common and rare diseases. Here, we evaluated the recommendations and information available from select clinical pharmacology studies in the therapeutic product labeling of new molecular entities (NMEs) approved from 2017 to 2019 for both common and rare diseases. A total of 151 NMEs, including 72 orphan and 79 non-orphan drugs, were analyzed for recommendations and information available related to food-drug interaction, drug-drug interaction, renal impairment, hepatic impairment, QT assessment, and human radiolabeled mass balance studies using data collected from the original labeling and other regulatory documents. The analysis showed no statistically significant difference in the recommendations between orphan and non-orphan drugs except for renal impairment related recommendations in section 8 of the labeling. Although not significant, fewer hepatic impairment labeling recommendations were available for orphan drugs when compared with non-orphan drugs. At the time of initial approval, 79 postmarketing requirements (PMRs) and postmarketing commitments (PMCs) for 33 orphan drugs and 39 PMRs and PMCs for 19 non-orphan drugs were established; with most difference observed for drug-drug interaction, hepatic impairment, and QT assessment. Overall, although there was a trend for more labeling recommendations and fewer postmarketing studies and clinical trials for non-orphan drugs, there appeared to be no substantial differences in how these select clinical pharmacology studies are leveraged during the development and approval of orphan and non-orphan drugs.

PMID:36165094 | DOI:10.1111/cts.13362

Categories
Nevin Manimala Statistics

Cross-sectional survey of husbandry for pet guinea pigs (Cavia porcellus) in New Zealand

N Z Vet J. 2022 Sep 27:1-12. doi: 10.1080/00480169.2022.2129854. Online ahead of print.

ABSTRACT

AIMS: To describe basic husbandry (veterinary care, substrate and bedding, toys, frequency of cleaning) provided to guinea pigs (Cavia porcellus) by a sample of owners in New Zealand.

METHODS: Respondents were invited to complete a survey disseminated through the social media channels of animal interest and advocacy groups (3 September 2020 to 3 November 2020). Respondents who agreed to participate were asked a range of questions regarding provision of husbandry to their oldest pet guinea pig. Descriptive statistics are reported here relating to husbandry, length of ownership, provision of substrate, bedding and toys, frequency of cleaning and veterinary care.

RESULTS: A total of 503 responses were received, of which 329 complete responses were analysed. Of these respondents, 208/329 (63.2%) had owned guinea pigs for more than 2 years. Most owners provided a cage with a wooden base as substrate (144/321, 44.9%), bedding (308/329; 93.6%) and toys (169/329; 51.1%). Half (176/329; 53.5%) of respondents reported taking their guinea pig to a veterinarian. Just over half of owners surveyed cleaned water (165/329; 50.1%) and food (181/329; 55.0%) bowls daily, and a third picked up droppings (109/329; 33.1%) daily.

CONCLUSIONS AND CLINICAL RELEVANCE: While owners provided an array of toys, and a range of bedding and substrate types to their guinea pigs, cages were cleaned out less frequently than recommended, and it was common for guinea pig cages to be cleaned out less frequently than recommended. Future research is required to provide robust and evidence-based links between husbandry and the welfare of pet guinea pigs.

PMID:36165091 | DOI:10.1080/00480169.2022.2129854

Categories
Nevin Manimala Statistics

Impact of high-dose glucocorticoid on endothelial damage after liver resection – a double-blinded randomized substudy

Eur J Gastroenterol Hepatol. 2022 Sep 20. doi: 10.1097/MxhEG.0000000000002449. Online ahead of print.

ABSTRACT

OBJECTIVES: Postoperative endothelial damage potentially results in increased vascular leakage, tissue edema and subsequent complications. The preventive effect of glucocorticoids on endothelial damage after surgery is sparsely described, including the relation between endothelial damage and the postoperative inflammatory response. Thus, we aimed to assess the preventive effect of high-dose glucocorticoids on postoperative endothelial damage, and the association between endothelial damage and inflammation after surgery.

METHODS: This was a predefined substudy of a randomized double-blinded clinical trial of methylprednisolone 10 mg/kg (high dose) vs. dexamethasone 8 mg (low dose) in patients undergoing liver resection at Rigshospitalet, Copenhagen. In total 25 patients undergoing major liver resection (11 in the high-dose group and 14 in the low-dose group) were included. The primary outcome was changed in five endothelial biomarkers and the secondary outcome was changes in inflammation [C-reactive protein (CRP)] for the first three postoperative days.

RESULTS: No statistically significant difference was found for any endothelial biomarkers postoperatively between the two groups (P > 0.15, for all). High-dose glucocorticoids significantly reduced CRP on day 3 compared to low-dose glucocorticoids [median difference on a postoperative day 3, 59.6 g/L, (84.2; 27.1), P < 0.002]. No significant correlation between endothelial damage and CRP levels was seen.

CONCLUSIONS: No significant effect of high- vs. low-dose glucocorticoids on development in endothelial biomarkers after major liver resection was observed. High-dose glucocorticoids reduce the inflammatory response though without correlation to endothelial damage. Future studies should assess the clinical impact of increased endothelial biomarkers for clinical perioperative outcomes.

PMID:36165063 | DOI:10.1097/MxhEG.0000000000002449

Categories
Nevin Manimala Statistics

Risk prediction model for early postoperative death in patients with hepatocellular carcinoma: a retrospective study based on random forest algorithm and logistic regression

Eur J Gastroenterol Hepatol. 2022 Sep 12. doi: 10.1097/MEG.0000000000002451. Online ahead of print.

ABSTRACT

BACKGROUND: At present, little is known about the risk factors of early postoperative death in patients with hepatocellular carcinoma (HCC).

METHODS: We collected the data of patients who were diagnosed with primary liver cancer between 2010 and 2015 in the Surveillance, Epidemiology, and End Results database and further allocated them to the training set and validation set. Univariate and multivariate logistic regression analysis was used to determine the independent influencing factors of early postoperative death of HCC patients. Random forest and Least absolute shrinkage and selection operator regression analysis were used to screen out vital variables for the construction of the nomogram. It was evaluated by receiver operating characteristic curve, calibration curve and decision curve analysis.

RESULTS: A total of 4154 patients were selected in this process, including 2647 patients with postoperative early death (outcome1) and 1507 patients with liver cancer-specific postoperative early death (outcome2). Surgery method, age category, marital status and tumor grade were the risk factors for early postoperative death. As for the liver cancer-specific early postoperative death, AJCC, surgery method, chemotherapy and tumor grade were independent prognostic factors. Early death and liver cancer-specific early death nomograms have an area under curves of 0.643 and 0.679 in the training set, respectively, and 0.617 and 0.688 in the validation set. The calibration curve and decision curve analysis shows that the nomograms have good performance.

CONCLUSION: This model provides an intuitive and practical tool for future studies based on large-scale cohorts by exploring the risk factors of early death in patients with HCCs undergoing surgery.

PMID:36165060 | DOI:10.1097/MEG.0000000000002451

Categories
Nevin Manimala Statistics

Cardiac involvement in Wilson’s disease: a retrospective cohort study

Eur J Gastroenterol Hepatol. 2022 Aug 25. doi: 10.1097/MEG.0000000000002432. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVES: Wilson’s disease (WD) is an inherited disorder with perturbations in copper metabolism and can cause multiorgan damage. This study aims to explore cardiac findings mainly based on electrocardiography (ECG) in WD patients.

METHODS: We retrospectively enrolled adult patients who were diagnosed with WD between January 2011 and December 2020. Demographic and clinical data were collected and reevaluated.

RESULTS: A total of 126 patients were included. There were 71 men and 55 women. The mean age was 27.2 years. Ninety-nine had hepatic presentation as the initial symptom and 27 had neuropsychiatric presentation as the initial symptom. Thirty-seven patients (29.4%) had cardiac manifestations. Of these patients, nine presented apparent cardiac symptoms (three with discontinuous chest tightness, three with dizziness, two with palpitation and one with atypical chest pain) and 28 had asymptomatic electrocardiography (ECG) abnormalities. Among the nine patients, four had second- or third-degree atrioventricular block, three had ST-segment change and two had ventricular tachycardia. ECG abnormalities in the 28 patients included increase in the width of the QRS complex in 8, atrial premature beats in 8, T-wave inversion in 5, P-wave inversion in 2, sinus bradycardia in 2, ST-segment change in 2, and coexistence of sinus bradycardia and T-wave inversion in 1. No statistical difference (P = 0.32) existed in the occurrence of ECG abnormalities between patients with hepatic presentation (27/99) and those with neuropsychiatric presentation (10/27).

CONCLUSION: Cardiac involvement is not rare in adult WD patients. We suggest that cardiac evaluation should be routinely performed in the population.

PMID:36165059 | DOI:10.1097/MEG.0000000000002432