Category: Statistics

Eur Radiol. 2022 Sep 27. doi: 10.1007/s00330-022-09151-1. Online ahead of print.

ABSTRACT

OBJECTIVES: To compare the image quality and diagnostic performance of conventional motion-corrected periodically rotated overlapping parallel line with enhanced reconstruction (PROPELLER) MRI sequences with post-processed PROPELLER MRI sequences using deep learning-based (DL) reconstructions.

METHODS: In this prospective study of 30 patients, conventional (19 min 18 s) and accelerated MRI sequences (7 min 16 s) using the PROPELLER technique were acquired. Accelerated sequences were post-processed using DL. The image quality and diagnostic confidence were qualitatively assessed by 2 readers using a 5-point Likert scale. Analysis of the pathological findings of cartilage, rotator cuff tendons and muscles, glenoid labrum and subacromial bursa was performed. Inter-reader agreement was calculated using Cohen’s kappa statistic. Quantitative evaluation of image quality was measured using the signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR).

RESULTS: Mean image quality and diagnostic confidence in evaluation of all shoulder structures were higher in DL sequences (p value = 0.01). Inter-reader agreement ranged between kappa values of 0.155 (assessment of the bursa) and 0.947 (assessment of the rotator cuff muscles). In 17 cases, thickening of the subacromial bursa of more than 2 mm was only visible in DL sequences. The pathologies of the other structures could be properly evaluated by conventional and DL sequences. Mean SNR (p value = 0.01) and CNR (p value = 0.02) were significantly higher for DL sequences.

CONCLUSIONS: The accelerated PROPELLER sequences with DL post-processing showed superior image quality and higher diagnostic confidence compared to the conventional PROPELLER sequences. Subacromial bursa can be thoroughly assessed in DL sequences, while the other structures of the shoulder joint can be assessed in conventional and DL sequences with a good agreement between sequences.

KEY POINTS: • MRI of the shoulder requires long scan times and can be hampered by motion artifacts. • Deep learning-based convolutional neural networks are used to reduce image noise and scan time while maintaining optimal image quality. The radial k-space acquisition technique (PROPELLER) can reduce the scan time and has potential to reduce motion artifacts. • DL sequences show a higher diagnostic confidence than conventional sequences and therefore are preferred for assessment of the subacromial bursa, while conventional and DL sequences show comparable performance in the evaluation of the shoulder joint.

PMID:36166084 | DOI:10.1007/s00330-022-09151-1

Unfallchirurgie (Heidelb). 2022 Sep 27. doi: 10.1007/s00113-022-01244-2. Online ahead of print.

ABSTRACT

Clinical trials must be planned and interpreted in the context of current best clinical and scientific evidence, undoubtedly provided by systematic reviews and meta-analyses, especially Cochrane Reviews. While many clinicians feel overwhelmed by this complex data source, few visualElements (e.g., the traffic light system of the Cochrane risk of bias [RoB‑2] tool, forest plots, etc.), together with indices such as the I² heterogeneity statistic, allow for a quick appraisal of all critical and necessary qualitative and quantitative information. The effectiveness of different treatment options can indirectly be assessed by methodological advancements like network meta-analyses.Point estimates of percentages are insufficient to describe the utility and value of a proposed novel intervention, which, in orthopedic and trauma surgery, often represents a step innovation. 95% confidence intervals and the so-called fragility index are helpful in determining the ultimate patient benefit.

PMID:36166082 | DOI:10.1007/s00113-022-01244-2

Eur J Trauma Emerg Surg. 2022 Sep 27. doi: 10.1007/s00068-022-02101-y. Online ahead of print.

ABSTRACT

PURPOSE: Most patients with a clinically suspected scaphoid fracture and normal initial radiograph are unnecessarily treated. Previously developed prediction rules using demographic and clinical risk are unable to accurately predict occult fractures. Adding other risk factors could enhance this. Therefore, we aim to explore if there are morphological risk factors of the wrist for sustaining a scaphoid fracture.

METHODS: We retrospectively included adult patients with a clinically suspected scaphoid fracture between 2013 and 2019 in our case-control study. There were 82 patients with a scaphoid fracture and 158 patients with a wrist contusion. Morphological risk factors were identified using statistical shape modelling (SSM) and linear measurements. Independent wrist shape variations on posteroanterior and lateral radiographs were captured in modes using SSM. Associations between outcomes and a scaphoid fracture were explored using logistic regression and the reliability was assessed.

RESULTS: Of the 15 posteroanterior modes and 8 lateral modes identified and linear measurements performed, 1 PA mode was associated with a scaphoid fracture (PA mode 4; OR 1.40, CI 1.04-1.93, p = 0.031). We described this mode as an ulna plus and narrower distal radius with more volar tilt and radial inclination. The reliability of the posteroanterior modes and linear measurements was mostly good/excellent and moderate/poor for the lateral modes.

CONCLUSION: There was one complex wrist shape significantly associated with a scaphoid fracture. Since the association was weak and the shape is difficult to identify radiographs, we believe this morphological risk factor would not enhance identifying occult scaphoid fractures in the future.

PMID:36166077 | DOI:10.1007/s00068-022-02101-y

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 U_{6 mm} (P < .0001), U₀ (P < .001), U₄₅ (P = .002), U₉₀ (P < .0001), U₁₃₅ (P = .004), S_{6 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

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

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

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

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

NO ABSTRACT

PMID:36166034 | DOI:10.1001/jama.2022.13600

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

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