Recent Publications by CFE Educators

OBJECTIVE

The impact of the COVID-19 pandemic on patients with inflammatory rheumatic diseases, such as ankylosing spondylitis (AS), has been variable. Here, we assess disease activity and health-related quality of life (HRQoL) through the pandemic in patients with AS.

METHODS

In the open-label extension (OLE) of the phase 2b BE AGILE study, patients with AS received 160 mg of subcutaneous bimekizumab every 4 weeks. We assessed Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS-CRP), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Quality of Life (ASQoL) scores in the OLE immediately before and during the COVID-19 pandemic (September 2019 to April 2021).

RESULTS

A total of 232 patients remained in the BE AGILE OLE and were included in this post hoc study at the start of the analysis period (September 1, 2019); 12 patients had a COVID-19 treatment-emergent adverse event, and no cases resulted in death. The number of missed bimekizumab doses due to COVID-19 (11 doses) was minimal, and missed assessments remained low (≤5%) compared with the prepandemic period. Mean ASDAS-CRP (1.8), BASDAI (2.4), and ASQoL scores (2.8) in the OLE were low at pre-pandemic baseline and remained stable at 1.7 to 1.8, 2.2 to 2.4, and 2.0 to 2.8, respectively, across successive 3-month periods immediately before and during the pandemic. ASDAS-CRP, BASDAI, and ASQoL stability was consistent across major study countries.

CONCLUSION

Disease activity and HRQoL remained stable during the COVID-19 pandemic in patients with AS receiving bimekizumab in the BE AGILE OLE, with no indication of negative effects on these outcomes.

INTRODUCTION

The impact of hepatorenal function on plasma biomarkers of neuropathology is unknown. Herein, we measured several plasma biomarkers in patients with cirrhosis.

METHODS

Plasma phosphorylated tau (p-tau181), neurofilament light chain (NfL), glial fibrillary acidic protein (GFAP), total tau (t-tau), and ubiquitin carboxyl-terminal hydrolase L1 (UCHL1) were measured in 135 adults with cirrhosis and 22 healthy controls using Simoa. Within cirrhosis, associations between biomarkers and hepatorenal function were explored using linear regression.

RESULTS

p-tau181, NfL, t-tau, and UCHL1 were increased 2- to 4-fold in cirrhosis, whereas GFAP was not increased. Within cirrhosis, creatinine moderately correlated with p-tau181 ( = 0.75, .01), NfL ( = 0.32, .01), and t-tau ( = 0.31, .01), but not GFAP ( = -0.01, = .88) or UCHL1 ( = -0.05, = .60), whereas albumin showed weak, inverse correlations: p-tau181 ( = -0.18, .01), NfL ( = -0.22, .01), GFAP ( = -0.17, .05), t-tau ( = -0.20, = .02), and UCHL1 ( = -0.15, = .09).

CONCLUSIONS

Elevated p-tau181, NfL, and t-tau in cirrhosis were associated with renal impairment and hypoalbuminemia, suggesting that hepatorenal function may be important when interpreting plasma biomarkers of neuropathology.

BACKGROUND

Echocardiographic measurements carry the promise of improving interrater (IR) agreement over subjective assessment. The aim of this study was to assess the effect of implementing a measurement-based protocol on IR agreement and accuracy in reporting of right ventricular (RV) systolic pressure in children. The effect of this reporting protocol on IR agreement in reporting RV dilation, hypertrophy, and systolic function was also evaluated.

METHODS

Five echocardiography readers reported their assessment of RV systolic pressure, dilation, hypertrophy, and systolic function on 40 deidentified echocardiograms using their individual accustomed methods and then using an agreed-upon protocol based solely on RV measurements. IR agreement was assessed using κ statistics. Accuracy of RV systolic pressure ratings was assessed using the McNemar test in comparison with hemodynamic data obtained by cardiac catheterization. The reliability of the RV measurements was assessed using intraclass correlation coefficient (ICC) and coefficient of variation.

RESULTS

IR agreement and accuracy of RV systolic pressure assessment improved after using the measurement-based protocol (agreement from 0.39 [95% CI, 0.27-0.5] to 0.62 [95% CI, 0.48-0.76] and accuracy from 18 of 40 to 29 of 40 [P = .03]). IR agreement of RV dilation improved (from 0.36 [95% CI, 0.25-0.48] to 0.63 [95% CI, 0.48-0.79]), while IR agreement of RV hypertrophy (from 0.29 [95% CI, 0.17-0.42] to 0.35 [95% CI, 0.15-0.55]) and RV systolic function (from 0.57 [95% CI, 0.45-0.69] to 0.53 [95% CI, 0.41-0.66]) did not improve. The reliability of the measurements was good (ICC > 0.8), except for RV free wall thickness (ICC = 0.62, coefficient of variation = 24%) and RV fractional area change (ICC = 0.47, coefficient of variation = 22%), suggesting a possible reason for the lack of improvement in IR agreement of RV hypertrophy and RV systolic function. Heteroscedasticity was observed in the reliability of RV measurements, with the ICC being significantly lower at larger magnitudes for all RV measurements.

CONCLUSIONS

Standardization of reporting protocols using RV measurements in place of subjective assessment improved IR agreement and accuracy of RV systolic pressure assessment. Reliable measurements (RV systolic pressure and dilation) resulted in improvement in IR agreement while unreliable measurements (RV hypertrophy and systolic function) did not. Special attention to measurements' reliability and heteroscedasticity of reliability is required when designing clinical protocols to decrease IR disagreement as a source of error.

OBJECTIVE

The aim of this study was to evaluate whether patients with invasive lobular carcinoma (ILC) are more likely to have discordant clinical and genomic risk than those with invasive ductal carcinoma (IDC) when using the 21-gene recurrence score (RS), and to assess overall survival outcomes of patients with 1-3 positive nodes and RS ≤25 with and without chemotherapy, stratified by histology.

METHODS

We performed a cohort study using the National Cancer Database and included patients with hormone receptor-positive, HER2-negative, stage I-III invasive breast cancer who underwent 21-gene RS testing. Our primary outcome was rate of discordant clinical and genomic risk status by histologic subtype. Propensity score matching was used to compare 60-month overall survival in individuals with 1-3 positive nodes and RS ≤25 who did and did not receive chemotherapy.

RESULTS

Overall, 186,867 patients were included in our analysis, including 37,685 (20.2%) patients with ILC. There was a significantly higher rate of discordant clinical and genomic risk in patients with ILC compared with IDC. Among patients with 1-3 positive nodes and RS ≤25, there was no significant difference in survival between those who did and did not receive chemotherapy in the IDC or ILC cohorts. Unadjusted exploratory analyses of patients under age 50 years with 1-3 positive nodes and RS ≤25 showed improved overall survival in IDC patients who received chemotherapy, but not among those with ILC.

CONCLUSION

Our findings highlight the importance of lobular-specific tools for stratifying clinical and genomic risk, as well as the need for histologic subtype-specific analyses in randomized trials.

OBJECTIVE

Airway stenosis-particularly multi-level-presents complex management challenges. This study assessed rates of tracheostomy, decannulation, and the number of surgeries required in patients with posterior glottic stenosis (PGS), multi-level airway stenosis (MLAS), and bilateral vocal fold paralysis (BVFP).

METHODS

Airway stenosis patients treated between 2016 and 2021 at three tertiary medical centers were identified. Demographics, etiology of stenosis, medical comorbidities, and patient-reported outcome measures (PROMs) were collected.

RESULTS

158 patients (84 women, mean age 56.98 ± 15.5 years) were identified (54 PGS, 38 MLAS, and 66 BVFP). 72.3% required tracheostomy, including 72.2%, 86.8%, and 63.6% in these groups, respectively. Decannulation rates were 43.6%, 21.2%, and 32.5% in these groups, respectively. Patients with MLAS had higher rates of tracheostomy than BVFP (p  0.05). However, decannulation rates were not different between groups (p > 0.05). MLAS required more surgeries (mean 4.0 ± 3.9) than PGS (2.4 ± 2.2, p = 0.02) or BVFP (1.0 ± 1.8, p  0.0001). Mean PROMs scores at the latest follow-up were abnormal: 15.4 ± 12.2 (Dyspnea Index), 19.9 ± 12.2 (Voice Handicap Index-10), and 9.67 ± 11.1 (Eating Assessment Tool-10). Co-morbidities present included body mass index >30 (41.4%), diabetes (31.8%), pulmonary disease (50.7%), gastroesophageal reflux disease (39.4%), autoimmune disease (22.9%), and tobacco use history (55.2%).

CONCLUSIONS

Airway stenosis is a challenging clinical problem that negatively impacts patients' quality of life and often requires numerous surgeries. PGS more frequently requires tracheostomy compared to BVFP, but patients can often decannulate successfully. Patients with multi-level stenosis have lower decannulation rates and require more surgeries than glottic stenosis alone; these patients may benefit from earlier and/or more aggressive intervention.

LEVEL OF EVIDENCE

4 Laryngoscope, 2022.