J Biopharm Stat. 2021 May 20:1-2. doi: 10.1080/10543406.2021.1928833. Online ahead of print.
NO ABSTRACT
PMID:34014125 | DOI:10.1080/10543406.2021.1928833
Can J Surg. 2021 May 20;64(3):E298-E306. doi: 10.1503/cjs.019619.
ABSTRACT
BACKGROUND: The acute care surgery (ACS) model has been shown to improve patient, hospital and surgeon-specific outcomes. To date, however, little has been published on its impact on residency training. Our study compared the emergency general surgery (EGS) operative experiences of residents assigned to ACS versus elective surgical rotations.
METHODS: Resident-reported EGS case logs were prospectively collected over a 9-month period across 3 teaching hospitals. Descriptive statistics were tabulated and group comparisons were made using χ2 statistics for categorical data and t tests for continuous data.
RESULTS: Overall, 1061 cases were reported. Resident participation exceeded 90%). Appendiceal and biliary disease accounted for 49.7% of EGS cases. Residents on ACS rotations reported participating in twice as many EGS cases per block as residents on elective rotations (12.64 v. 6.30 cases, p < 0.01). Most cases occurred after hours while residents were on call rather than during daytime ACS hours (78.8% v. 21.1%, p < 0.01). Senior residents were more likely than junior residents to report having a primary operator role (71.3% v. 32.0%, p < 0.01). Although the timing of cases made no difference in the operative role of senior residents, junior residents assumed the primary operator role more often during the daytime than after hours (50.0% v. 33.1%, p = 0.01).
CONCLUSION: Despite implementation of the ACS model, residents in our program obtained most of their EGS operative experience after hours while on call. Although further research is needed, our study suggests that improved daytime access to the operating room may represent an opportunity to improve the quantity and quality of the EGS operative experience at our academic network.
PMID:34014063 | DOI:10.1503/cjs.019619
Mol Genet Genomic Med. 2021 May 20:e1705. doi: 10.1002/mgg3.1705. Online ahead of print.
ABSTRACT
BACKGROUND: Different genetic variants in hormone-regulating pathways have been identified to influence the risk of breast cancer. This study aimed to evaluate the association of CYP19A1 rs10046 and rs700519 polymorphisms with the risk, clinicopathological factors and prognosis of breast cancer.
METHODS: In a case-control study, rs10046 and rs700519 polymorphisms were genotyped using ARMS-PCR and high-resolution melting (HRM), respectively, in a total of 702 females. Statistical analysis and evaluation of haplotypes and linkage disequilibrium were performed using SPSS v16, PHASE and 2LD.
RESULTS: Although no association of rs700519 with breast cancer was observed, rs10046 in different genetic models as well as C-C/C-T and C-C/C-C diplotypes, revealed the association with the risk of breast cancer (p < 0.05). Moreover, the rs700519-C allele was shown to be associated with longer overall survival. In contrast, the T-T haplotype conferred s a shorter overall survival. rs700519-C allele was also significantly associated with menarche age.
CONCLUSION: Based on the identified independent association between CYP19A1 diplotypes and rs700519-C allele with the risk and prognosis of the disease, the gene region and its genetic variants may have a diagnostic and prognostic role in breast cancer development. Further confirmation using other variants in this locus can validate these findings.
PMID:34014013 | DOI:10.1002/mgg3.1705
J Eur Acad Dermatol Venereol. 2021 May 20. doi: 10.1111/jdv.17387. Online ahead of print.
ABSTRACT
BACKGROUND: Several clinician-rated scoring systems are available to assess nail psoriasis severity, but only one has been partially validated.
OBJECTIVE: To develop and validate the Physician’s Global Assessment of Fingernail Psoriasis (PGA-F), a new clinician-rated severity scale.
METHODS: A literature review, concept elicitation, pilot cognitive debriefing, and clinical expert consultations informed development of the PGA-F. A multi-stage mixed methods analysis consisted of practicing dermatologist cognitive interviews (n=10) for instrument clarity, relevance, and comprehensiveness. Inter-rater reliability (IRR) of ratings from dermatologists (n=22) and clinical trial investigators (n=8) was tested using many-facet Rasch analysis. Concurrent validity between the PGA-F and modified Nail Psoriasis Severity Index (mNAPSI) at screening and baseline was assessed along with degree of discrimination. Intraclass correlation coefficient (ICC) for single raters at multiple assessments determined IRR.
RESULTS: The PGA-F synthesizes severity ratings across multiple disease features that classifies individuals into 1 of 5 levels (clear to severe). Cognitive interviews confirmed content validity: all (n=10, 100%) participants agreed clinical criteria were consistent with nail psoriasis; no mismatched severity levels; and training photographs were realistic representations. All PGA-F items were locally independent and targeted patients along the severity continuum with complementary precision (item fit statistics: < the 1.5 acceptability threshold; exact agreements amongst the dermatologists [44%] and trial investigators [61.5%] exceeded 40% acceptability threshold). Clinician reliability exceeded the threshold of acceptability for dermatologists and clinical trial investigators: 0.85 and 0.73, respectively. There was adequate correlation (>0.30) between mNAPSI and PGA-F at baseline and Week 26 with significant discrimination of severity and monotonic increases on the mNAPSI for each level of categorical severity on the PGA-F. ICC results for each type of IRR indicate that clinicians were consistent in individual patient ratings.
CONCLUSION: The PGA-F is a rapid, valid, and reliable clinician-rated severity scale for use in clinical practice and research.
PMID:34014011 | DOI:10.1111/jdv.17387
J Magn Reson Imaging. 2021 May 20. doi: 10.1002/jmri.27629. Online ahead of print.
ABSTRACT
BACKGROUND: Flow related artifacts in continuous arterial spin labeling (cASL) zero-echo-time (ZTE) magnetic resonance angiography (MRA) could influence the vasculature visualization.
PURPOSE: To investigate the clinical feasibility for the intracranial artery diseases assessment by utilizing hybrid ASL-ZTE-MRA (hASL-ZTE-MRA).
STUDY TYPE: Prospective, technical development.
POPULATION: Sixty-seven subjects with known/suspected cerebrovascular diseases.
FIELD STRENGTH/SEQUENCE: Gradient echo based cASL-/hASL- ZTE-MRA at 3.0 T.
ASSESSMENT: Subjective/objective evaluation for sound-levels. Image quality (IQ), signal-to-noise ratio (SNR), and contrast-to-noise ratio (CNR) were analyzed within artery segments. Stenotic grading, aneurysm measurement, and signal intensity of lesions were further analyzed.
STATISTICAL TESTS: Kolmogorov-Smirnov test for data normality check. Between two MRAs: Wilcoxon signed-rank test for sound experience/IQ ratings analysis; Paired t test for SNR/CNR comparison. One-way analysis of variance for sound intensity comparison. For stenosis grading/aneurysm measurement: Kendall’s W test/intraclass correlation coefficient (ICC) for interobserver agreement test within each modality, weighted kappa statistics/ICC for intermodality agreement test between each MRA and computed tomography angiography.
RESULTS: Sound-level perception/intensity was similar (P = 0.86, P = 0.55) between MRAs. The mean IQ score for hASL-ZTE-MRA was on diagnostic scale and slightly higher (P < 0.05) than that of cASL-ZTE-MRA. hASL-ZTE-MRA provided higher (P < 0.05) SNR/CNR than that of cASL-ZTE-MRA. Signal uniformity was improved on hASL-ZTE-MRA, particularly among the anterior circulation (P < 0.05). Comparing to cASL-ZTE-MRA, on hASL-ZTE-MRA, stenotic lesions were accurately assessed; flow in the stent or aneurysm remnant was better depicted (P < 0.05); AVM nidus was preferred with increased SNR (P < 0.05). No significant differences for the aneurysm measurement were found between MRAs (P = 0.95), in addition to the slightly higher SNR (P < 0.05) on hASL-ZTE-MRA.
DATA CONCLUSION: Comparing to cASL-ZTE-MRA, hASL-ZTE-MRA is robust and feasible for the evaluation of intracranial artery diseases with diagnostic IQ, improved vessel contrast, and better signal heterogeneity.
LEVEL OF EVIDENCE: 2 TECHNICAL EFFICACY: 2.
PMID:34014010 | DOI:10.1002/jmri.27629
Mov Disord. 2021 May 20. doi: 10.1002/mds.28650. Online ahead of print.
ABSTRACT
BACKGROUND: Potential therapeutic targets and clinical trials for Huntington’s disease have grown immensely in the last decade. However, to improve clinical trial outcomes, there is a need to better characterize profiles of signs and symptoms across different epochs of the disease to improve selection of participants.
OBJECTIVE: The objective of the present study was to best distinguish longitudinal trajectories across different Huntington’s disease progression groups.
METHODS: Clinical and morphometric imaging data from 1082 participants across IMAGE-HD, TRACK-HD, and PREDICT-HD studies were combined, with longitudinal times ranging between 1 and 10 years. Participants were classified into 4 groups using CAG and age product. Using multivariate linear mixed modeling, 63 combinations of markers were tested for their sensitivity in differentiating CAG and age product groups. Next, multivariate linear mixed modeling was applied to define the best combination of markers to track progression across individual CAG and age product groups.
RESULTS: Putamen and caudate volumes, individually and/or combined, were identified as the best variables to both differentiate CAG and age product groups and track progression within them. The model using only caudate volume best described advanced disease progression in the combined data set. Contrary to expectations, combining clinical markers and volumetric measures did not improve tracking longitudinal progression.
CONCLUSIONS: Monitoring volumetric changes throughout a trial (alongside primary and secondary clinical end points) may provide a more comprehensive understanding of improvements in functional outcomes and help to improve the design of clinical trials. Alternatively, our results suggest that imaging deserves consideration as an end point in clinical trials because of the prospect of greater sensitivity. © 2021 International Parkinson and Movement Disorder Society.
PMID:34014005 | DOI:10.1002/mds.28650
J Ultrasound Med. 2021 May 20. doi: 10.1002/jum.15756. Online ahead of print.
ABSTRACT
OBJECTIVES: The aim of the study was to evaluate the clinical and sonographic parameters associated with a correct or incorrect diagnosis of adnexal torsion made by resident/attending physicians who are not expert sonographers.
METHODS: A retrospective study design included women who presented to the Emergency Department (ED) of a tertiary medical center between 2010 and 2019 with acute lower abdominal pain, who were subsequently diagnosed laparoscopically with adnexal torsion. Women who were correctly diagnosed in the ED by an obstetrician-gynecologist who was not an expert sonographer were compared for clinical and sonographic parameters with women who were initially incorrectly diagnosed and underwent a second ultrasound examination by an expert sonographer following admission.
RESULTS: Of 118 women with surgically proven adnexal torsion, 76 were correctly diagnosed in the ED and 42 were initially incorrectly diagnosed. The correctly diagnosed group was characterized by a significantly shorter mean time from admission to surgery, higher rate of vomiting, shorter duration of abdominal pain, and higher rate of prior torsion (P < .05). Physicians who made the correct diagnosis utilized more sonographic parameters than those who did not, namely ovarian size, ovarian edema, and Doppler flow. The correctly diagnosed group had a higher rate of bluish-black (ischemic) adnexa at laparoscopy, but a higher rate of recovery following detorsion.
CONCLUSIONS: Physicians in the ED should be alerted to the need to address some basic sonographic features when adnexal torsion is suspected. The diagnostic accuracy of adnexal torsion can be improved by utilizing simple sonographic markers, even in the ED setting.
PMID:34013996 | DOI:10.1002/jum.15756
Anat Histol Embryol. 2021 May 20. doi: 10.1111/ahe.12679. Online ahead of print.
ABSTRACT
The aim of the study was to determine identification, three-dimensional modelling, and morphometry of intracranial arteries in New Zealand Rabbit by using computed tomography angiography. A total of 20 adult New Zealand Rabbits from both sexes were used in the study. General anaesthesia procedure was followed before computed tomography angiography imaging. Rabbits were placed in a prone position for imaging. Computed tomography angiography imaging was performed by injecting contrast agent into vena auricularis marginalis of rabbits. Morphometric measurements of the specified points were taken by MIMICS program using the computed tomography angiography images acquired. Three-dimensional intracranial artery model was prepared from the two-dimensional images on the same program. Measurements were statistically compared in terms of sex and side. It was observed in the study that arteria basilaris was generated by bilateral arteria vertebralis at the basal level of medulla oblongata. In the study, a statistically significant difference was determined only in diameter values of arteria cerebri caudalis dextra et sinistra in both female and male rabbits. On the other hand, no statistically significant difference was determined with respect to the side. Consequently, we think that the data of the present study will contribute to further studies on cerebrovascular pathology, clinicians or researchers.
PMID:34013993 | DOI:10.1111/ahe.12679
Headache. 2021 May 20. doi: 10.1111/head.14120. Online ahead of print.
ABSTRACT
OBJECTIVES: To describe the methodology and implications of the patient-identified most bothersome symptom (PI-MBS) measure used in the phase 3, multicenter, randomized, double-blind, placebo-controlled, and parallel-group PROMISE-2 trial and to evaluate the contribution of this measure to the assessment of the preventive migraine benefits of treatment.
BACKGROUND: Although freedom from MBS is a coprimary endpoint in acute migraine treatment trials, its evaluation in preventive migraine trials is limited. The PROMISE-2 study assessed a unique PI-MBS measure as a secondary endpoint.
METHODS: This was a secondary analysis of data from the PROMISE-2 study. Adults with chronic migraine (CM) were randomized to receive intravenous (IV) eptinezumab 100 mg, eptinezumab 300 mg, or placebo, administered on day 0 and every 12 weeks. At the screening visit, patients were asked to verbally describe the MBS associated with their CM; the question format was open ended. At subsequent visits, patients were asked to rate the overall change in severity of their MBS from study inception to that time point, using a 7-point ordinal scale ranging from “very much worse” (-3) to “very much improved” (+3). Patients completed the Patient Global Impression of Change (PGIC) assessment during the same visits, using an identical rating scale and recall period. Endpoints were summarized descriptively; post hoc correlations using the methodologies of Pearson and Spearman were calculated to evaluate relationships between PGIC and PI-MBS and between PGIC and mean monthly migraine days (MMDs; primary efficacy endpoint in PROMISE-2).
RESULTS: Altogether, 1072 patients received treatment (eptinezumab 100 mg, n = 356; eptinezumab 300 mg, n = 350; placebo, n = 366) and were included in the analysis. There were 23 unique MBS identified; those reported by ≥10 patients included light sensitivity (18.7%), nausea/vomiting (15.1%), pain with activity (13.7%), pain (12.4%), headache (11.2%), sound sensitivity (7.3%), throbbing/pulsating pain (4.7%), cognitive disruption (4.1%), fatigue (2.4%), mood changes (1.5%), and sensitivity to smell (0.9%). Four weeks after the first dose (week 4), the rates of much or very much improvement in PI-MBS were higher with eptinezumab 100 mg (45%) and 300 mg (57%) than with placebo (29%). Four weeks after the second dose (week 16), the proportions with much or very much improvement in PI-MBS had increased to 58%, 65%, and 36%, respectively. At each time point, the percentages of patients with PGIC ratings of much or very much improved were similar to those for patient-reported improvement in PI-MBS. Patient ratings of changes in PI-MBS and PGIC correlated strongly across time points (Pearson, r range, 0.83-0.88; Spearman, r range, 0.83-0.89); the absolute value of the correlations was greater than the correlation among changes in MMDs and PGIC (Pearson, r range, -0.49 to -0.52; Spearman, r range, -0.49 to -0.52).
CONCLUSIONS: Among patients with CM in the PROMISE-2 study, a broad range of PI-MBS was reported at baseline. Throughout the study, patients treated with eptinezumab reported greater improvement in their PI-MBS severity compared with placebo recipients, and this improvement correlated strongly with PGIC findings. Collectively, these results indicate that PI-MBS is a promising and novel outcome measure for preventive trials of CM and thus may provide a unique patient-centered approach for identifying and measuring the burden of migraine symptoms that matter most to each patient, as well as the benefits of treatment.
PMID:34013992 | DOI:10.1111/head.14120
Laryngoscope. 2021 May 20. doi: 10.1002/lary.29628. Online ahead of print.
ABSTRACT
OBJECTIVES: Assesses whether preoperative functional testing can distinguish vestibular schwannomas from facial nerve schwannomas medial to the labyrinthine segment.
STUDY DESIGN: Retrospective cohort.
METHODS: Retrospectively review surgically managed intracranial facial and vestibular schwannomas between January 2015 and December 2019 at two tertiary care centers. Patients with neurofibromatosis 2 and surgery for recurrence were excluded. Preoperative functional testing to include House-Brackmann scores, electroneuronography (ENoG), cervical vestibular evoked myogenic potentials (cVEMP), caloric testing, acoustic brainstem responses (ABRs), acoustic reflexes, and audiograms was compared between the two groups of schwannomas.
RESULTS: Twelve facial and 128 vestibular schwannomas met inclusion criteria. In only one case was a facial schwannoma diagnosed preoperatively from imaging. No statistically significant difference was found in preoperative House-Brackmann scores, ENoG, cVEMP, caloric testing, ABRs, or acoustic reflexes. Pure tone average was worse in the vestibular schwannoma group (63 dB [95% CI: 58-68 dB] vs. 46 dB [95% CI: 34-58 dB], P = .01), and the difference was more apparent in the lower frequencies. Word recognition score was better in the facial schwannoma group (66% [95% CI: 45-86%] vs. 41% [95% CI: 34-47%], P = .02).
CONCLUSION: Specialized preoperative functional evaluation of the nerves of the internal auditory canal cannot reliably predict the presence of an intracranial facial schwannoma. Hearing is better in facial schwannomas, particularly in the lower frequencies. This should raise the index of suspicion for an intracranial facial schwannoma, especially in candidates for hearing preservation vestibular schwannoma surgery.
LEVEL OF EVIDENCE: Level 3 Laryngoscope, 2021.
PMID:34013983 | DOI:10.1002/lary.29628