Bulletin of Computer Science and Electrical Engineering (BCSEE)
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Predictive Value of Sequential Organ Failure Assessment Score across Patients with and without COVID-19 Infection
No full textSequential organ failure assessment (SOFA) scores are commonly used in crisis standards of care policies to assist in resource allocation. The relative predictive value of SOFA by coronavirus disease (COVID-19) infection status and among racial and ethnic subgroups within patients infected with COVID-19 is unknown.
To evaluate the accuracy and calibration of SOFA in predicting hospital mortality by COVID-19 infection status and across racial and ethnic subgroups.
We performed a retrospective cohort study of adult admissions to the University of Miami Hospital and Clinics inpatient wards (July 1, 2020-April 1, 2021). We primarily considered maximum SOFA within 48 hours of hospitalization. We assessed accuracy using the area under the receiver operating characteristic curve (AUROC) and created calibration belts. Considered subgroups were defined by COVID-19 infection status (by severe acute respiratory syndrome coronavirus 2 polymerase chain reaction testing) and prevalent racial and ethnic minorities. Comparisons across subgroups were made with DeLong testing for discriminative accuracy and visualization of calibration belts.
Our primary cohort consisted of 20,045 hospitalizations, of which 1,894 (9.5%) were COVID-19 positive. SOFA was similarly accurate for COVID-19-positive (AUROC, 0.835) and COVID-19-negative (AUROC, 0.810;
= 0.15) admissions but was slightly better calibrated in patients who were positive for COVID-19. For those with critical illness, maximum SOFA score accuracy at critical illness onset also did not differ by COVID-19 status (AUROC, COVID-19 positive vs. negative: intensive care unit admissions, 0.751 vs. 0.775;
= 0.46; mechanically ventilated, 0.713 vs. 0.792,
= 0.13), and calibration was again better for patients positive for COVID-19. Among patients with COVID-19, SOFA accuracy was similar between the non-Hispanic White population (AUROC, 0.894) and racial and ethnic minorities (Hispanic White population: AUROC, 0.824 [
vs. non-Hispanic White = 0.05]; non-Hispanic Black population: AUROC, 0.800 [
= 0.12]; Hispanic Black population: AUROC, 0.948 [
= 0.31]). This similar accuracy was also found for those without COVID-19 (non-Hispanic White population: AUROC, 0.829; Hispanic White population: AUROC, 0.811 [
= 0.37]; Hispanic Black population: AUROC, 0.828 [
= 0.97]; non-Hispanic Black population: AUROC, 0.867 [
= 0.46]). SOFA was well calibrated for all racial and ethnic groups with COVID-19 but estimated mortality more variably and performed less well across races and ethnicities without COVID-19.
SOFA accuracy does not differ by COVID-19 status and is similar among racial and ethnic groups both with and without COVID-19. Calibration is better for COVID-19-infected patients and, among those without COVID-19, varies by race and ethnicity
Fibrates for the Treatment of Primary Biliary Cholangitis Unresponsive to Ursodeoxycholic Acid: An Exploratory Study
No full textAim: Up to 40% of patients with primary biliary cholangitis (PBC) will have a suboptimal biochemical response to ursodeoxycholic acid (UDCA), which can be improved by the addition of fibrates. This exploratory study aims to evaluate the long-term real-life biochemical response of different fibrates, including ciprofibrate, in subjects with UDCA-unresponsive PBC.Methods: The Brazilian Cholestasis Study Group multicenter database was reviewed to assess the response rates to UDCA plus fibrates in patients with UDCA-unresponsive PBC 1 and 2 years after treatment initiation by different validated criteria.Results: In total, 27 patients (100% women, mean age 48.9 +/- 9.2 years) with PBC were included. Overall response rates to fibrates by each validated criterion varied from 39 to 60% and 39-76% at 12 and 24 months after treatment combination, respectively. Combination therapy resulted in a significant decrease in ALT and ALP only after 2 years, while GGT significantly improved in the first year of treatment. Treatment response rates at 1 and 2 years appear to be comparable between ciprofibrate and bezafibrate using all available criteria.Conclusion: Our findings endorse the efficacy of fibrate add-on treatment in PBC patients with suboptimal response to UDCA. Ciprofibrate appears to be at least as effective as bezafibrate and should be assessed in large clinical trials as a possibly new, cheaper, and promising option for treatment of UDCA-unresponsive PBC patients
Defining cognitive impairment in amyotrophic lateral sclerosis: an evaluation of empirical approaches
No full textObjective: Amyotrophic lateral sclerosis (ALS) is a multi-system disorder characterized primarily by motor neuron degeneration, but may be accompanied by cognitive dysfunction. Statistically appropriate criteria for establishing cognitive impairment (CI) in ALS are lacking. We evaluate quantile regression (QR), that accounts for age and education, relative to a traditional two standard deviation (SD) cutoff for defining CI. Methods: QR of cross-sectional data from a multi-center North American Control (NAC) cohort of 269 healthy adults was used to model the 5
th
percentile of cognitive scores on the Edinburgh Cognitive and Behavioral ALS Screen (ECAS). The QR approach was compared to traditional two SD cutoff approach using the same NAC cohort (2SD-NAC) and to existing UK-based normative data derived using the 2SD approach (2SD-UK) to assess the impact of cohort selection and statistical model in identifying CI in 182 ALS patients. Results: QR-NAC models revealed that age and education impact cognitive performance on the ECAS. Based on QR-NAC normative cutoffs, the frequency of CI in the 182 PENN ALS patients was 15.9% for ALS specific, 12.6% for ALS nonspecific, and 15.4% for ECAS total. This frequency of CI is substantially more conservative in comparison to the 2SD-UK (20.3%-34.6%) and modestly more conservative to the 2SD-NAC (14.3%-16.5%) approaches for estimating CI. Conclusions: The choice of normative cohort has a substantial impact and choice of statistical method a modest impact on defining CI in ALS. This report establishes normative ECAS thresholds to identify whether ALS patients in the North American population have CI
Frontiers in Lichen Planopilaris and Frontal Fibrosing Alopecia Research: Pathobiology Progress and Translational Horizons
No full textLichen planopilaris (LPP) and frontal fibrosing alopecia (FFA) are primary, lymphocytic cicatricial hair loss disorders. These model epithelial stem cell (SC) diseases are thought to result from a CD8+ T-cell‒dominated immune attack on the hair follicle (HF) SC niche (bulge) after the latter has lost its immune privilege (IP) for as yet unknown reasons. This induces both apoptosis and pathological epithelial‒mesenchymal transition in epithelial SCs, thus depletes the bulge, causes fibrosis, and ultimately abrogates the HFs’ capacity to regenerate. In this paper, we synthesize recent progress in LPP and FFA pathobiology research, integrate our limited current understanding of the roles that genetic, hormonal, environmental, and other factors may play, and define major open questions. We propose that LPP and FFA share a common initial pathobiology, which then bifurcates into two distinct clinical phenotypes, with macrophages possibly playing a key role in phenotype determination. As particularly promising translational research avenues toward direly needed progress in the management of these disfiguring, deeply distressful cicatricial alopecia variants, we advocate to focus on the development of bulge IP and epithelial SC protectants such as, for example, topically effective, HF‒penetrating and immunoinhibitory preparations that contain tacrolimus, peroxisome proliferator–activated receptor-γ, and/or CB1 agonists
Geographical Differences in the Self-Reported Functional Impairment of People With Human Immunodeficiency Virus (HIV) and Associations With Cardiometabolic Risk
No full textBackground We sought to explore multinational differences in functional status by global burden of disease (GBD) regions in the REPRIEVE cohort. Methods REPRIEVE is a prospective, double-blind, randomized, placebo-controlled, multicenter, phase III primary cardiovascular prevention study of pitavastatin calcium vs placebo among people with human immunodeficiency virus (HIV, PWH) ages 40-75 on antiretroviral therapy (ART). GBD super regions were defined using World Health Organization classifications. Participants were categorized by impairment on the Duke Activity Status Instrument (DASI: none, some, moderate, severe). Logistic regression models examined risk factors and GBD regions associated with functional impairment. The association between functional impairment and cardiometabolic risk was also explored. Results Of 7736 participants, the majority were from high-income countries (n = 4065), were male (65%), and had received ART for >= 10 years. The median DASI score was 58.2 (interquartile range [IQR] 50.2, 58.2); 36% reported at least some impairment. In adjusted analyses, functional impairment was significantly more frequent among participants from Southeast/East Asia. Other factors associated with greater impairment included female sex, Black race, older age, current/former smoking, higher body mass index, use of ART for >= 10 years, and select ART regimens; differences were seen in risks across GBD regions. Functional impairment was associated with increased cardiometabolic risk. Conclusions Over 1/3 of middle-aged and older PWH in a global cohort across diverse GBD regions demonstrate functional impairments. The associations between DASI and cardiometabolic risk suggest that a measure of functional status may improve risk prediction; these longitudinal associations will be further investigated over REPRIEVE trial follow-up.
In a multinational cohort of human immunodeficiency virus (HIV), more than one-third of participants reported differences in self-reported functional status. Differences in risk factors were associated with functional status across global disease burden regions, and associated with cardiometabolic risk
Mental Health Mediates the Association Between Gender-Based Violence and HIV Treatment Engagement in US Women
No full textGender-based violence (GBV) is associated with poorer engagement in HIV care and treatment. However, there is a dearth of research on the psychological (eg, mental health) and structural (eg, food insecurity) factors that mediate and moderate this association. GBV could lead to poor mental health, which in turn affects adherence, whereas food insecurity could worsen the effect of GBV on engagement in care. This study uses data from the Women's Interagency HIV Study to address these gaps.
Women completed 6 assessments from 2013 to 2016 on GBV, mental health, food insecurity, adherence to antiretroviral therapy, and missed HIV care appointments in the past 6 months. Multilevel logistic regression models estimated associations between GBV and engagement in care and whether associations were mediated by depression, generalized anxiety disorder (GAD), and posttraumatic stress disorder (PTSD) and moderated by food insecurity.
GBV was associated with higher odds of suboptimal adherence (adjusted odds ratio: 1.88; 95% confidence interval: 1.24 to 2.87) and missed appointments (adjusted odds ratio: 1.76; 95% confidence interval: 1.16 to 2.67). The association between GBV and adherence was mediated by depressive symptoms, GAD, and PTSD, accounting for 29.7%, 15.0%, and 16.5%, respectively, of the total association. The association between GBV and missed appointments was mediated by depression and GAD, but not PTSD, with corresponding figures of 25.2% and 19.7%. Associations did not differ by food insecurity.
GBV is associated with suboptimal engagement in care, which may be explained by mental health. Interventions should address women's mental health needs, regardless of food insecurity, when improving engagement in HIV care
High-Quality Surgery for Gallbladder Carcinoma: Rare, Associated with Disparity, and Not Substitutable by Chemotherapy
No full textOncologic surgery for T1b-T3 gallbladder carcinoma (GBC) consists of gallbladder fossa resection or bisegmentectomy IVb/V with negative margins and portal/retropancreatic lymphadenectomy. Frequency of high quality oncologic surgery, factors associated with its use, and the ability of chemotherapy to rescue low-quality surgery (LQS) remain unknown.
The NCDB was queried for patients diagnosed with stage I-III (T1b-T3) GBC undergoing curative-intent surgery from 2004 to 2016. These patients were divided into two groups based on receiving high quality surgery (HQS) or not; HQS was defined as cholecystectomy with partial hepatectomy, lymph node harvest ≥ 6, and negative margins. Logistic regression and Kaplan-Meier survival analyses were performed.
A total of 3796 patients met inclusion criteria; only 364 (9.6%) met HQS criteria, and 3432 (90.4%) did not achieve HQS and were deemed low-quality surgery (LQS). HQS was associated with improved median overall survival (55.1 vs. 25.5 months, P < .001). Adjuvant chemotherapy (AC) was not able to rescue LQS with poorer survival compared to HQS without AC (27.9 vs 55.1 months, P < .001). Factors associated with HQS included private insurance (OR 1.809, P < .001), higher income (OR 1.380, P = .038), urban/rural residence (vs metropolitan) (OR 1.641, P = .001), higher education (OR 1.342, P = .031), Medicaid expansion states (OR 1.405, P = .005), stage 3 GBC (OR 1.642, P = .020), and reresection (OR 2.685, P < .001). Factors associated with LQS included older age (OR 0.974, P < .001), comorbidities (OR 0.701, P = .004), and laparoscopic approach (0.579, P < .001). Facility type incrementally improved HQS rate (integrated cancer network vs. comprehensive community, 9.8% vs. 6.1%, OR 1.694, P = .003; academic/research center vs. integrated cancer network, 14.9% vs. 9.8%, OR 1.599, P = .003).
While HQS for GBC strongly improves survival, it is infrequently practiced. The newly identified factors that improve survival for GBC, such as centralization, open approach, and insurance coverage, are modifiable and, therefore, should be considered to achieve optimal outcomes
Phase II Randomized Trial of Transoral Surgery and Low-Dose Intensity Modulated Radiation Therapy in Resectable p16+ Locally Advanced Oropharynx Cancer: An ECOG-ACRIN Cancer Research Group Trial (E3311)
No full textPURPOSE
Definitive or postoperative chemoradiation (CRT) is curative for human papillomavirus–associated (HPV+) oropharynx cancer (OPC) but induces significant toxicity. As a deintensification strategy, we studied primary transoral surgery (TOS) and reduced postoperative radiation therapy (RT) in intermediate-risk HPV+ OPC.
METHODS
E3311 is a phase II randomized trial of reduced- or standard-dose postoperative RT for resected stage III-IVa (American Joint Committee on Cancer-seventh edition) HPV+ OPC, determined by pathologic parameters. Primary goals were feasibility of prospective multi-institutional study of TOS for HPV+ OPC, and oncologic efficacy (2-year progression-free survival) of TOS and adjuvant therapy in intermediate-risk patients after resection. TOS plus 50 Gy was considered promising if the lower limit of the exact 90% binomial confidence intervals exceeded 85%. Quality of life and swallowing were measured by functional assessment of cancer therapy-head and neck and MD Anderson Dysphagia Index.
RESULTS
Credentialed surgeons performed TOS for 495 patients. Eligible and treated patients were assigned as follows: arm A (low risk, n = 38) enrolled 11%, intermediate risk arms B (50 Gy, n = 100) or C (60 Gy, n = 108) randomly allocated 58%, and arm D (high risk, n = 113) enrolled 31%. With a median 35.2-month follow-up for 359 evaluable (eligible and treated) patients, 2-year progression-free survival Kaplan-Meier estimate is 96.9% (90% CI, 91.9 to 100) for arm A (observation), 94.9% (90% CI, 91.3 to 98.6]) for arm B (50 Gy), 96.0% (90% CI, 92.8 to 99.3) for arm C (60 Gy), and 90.7% (90% CI, 86.2 to 95.4) for arm D (66 Gy plus weekly cisplatin). Treatment arm distribution and oncologic outcome for ineligible or step 2 untreated patients (n = 136) mirrored the 359 evaluable patients. Exploratory comparison of functional assessment of cancer therapy-head and neck total scores between arms B and C is presented.
CONCLUSION
Primary TOS and reduced postoperative RT result in outstanding oncologic outcome and favorable functional outcomes in intermediate-risk HPV+ OPC
Improving eligibility criteria for first-line trials for patients with DLBCL using a US-based Delphi-method survey
No full textRecent first-line randomized controlled trials (RCTs) for patients with diffuse large B-cell lymphoma (DLBCL) have shown negative results, which may be due in part to onerous eligibility criteria limiting enrollment of poor-risk patients who require immediate treatment. We conducted a Delphi-method survey with lymphoma experts in the United States to define recommendations for essential and potentially unnecessary enrollment criteria for modern first-line DLBCL RCTs aimed at increasing clinical diversity of ensuing study groups. We first tabulated enrollment criteria from 19 DLBCL RCTs spanning the rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) era to identify common eligibility criteria from prior DLBCL RCTs for inclusion in the Delphi-method survey. We tabulated 451 total eligibility criteria comprising 51 criterion categories across 19 first-line DLBCL RCTs in the R-CHOP era. We then surveyed lymphoma clinical trial experts representing 8 academic medical centers in the United States regarding essential and unnecessary eligibility criteria for modern DLBCL RCTs. Seventeen of 29 invited clinical investigators completed the round-1 questionnaire (response rate, of 58.6%), 15 of 17 round-1 participants (88.2%) completed the round-2 survey, and all round-1 participants reviewed finalized recommendations for eligibility criteria for modern first-line DLBCL RCTs. We defined consensus recommendations for 31 modernized eligibility criteria including threshold values for 10 quantitative eligibility criteria aimed at facilitating enrollment of a clinically diverse study population in first-line DLBCL RCTs designed to improve standard-of-care therapy
Length and Age at Maturity Estimation in Two Commercial Atlantic Grouper Species
No full textSnowy grouper (Hyporthodus niveatus) and Scamp (Mycteroperca phenax) are two commercially valuable species of grouper inhabiting the continental shelf off the Southeastern coast of the United States. In recent decades, the management plans for both of these species have undergone considerable revisions involving reductions in annual catch limits and/or vessel trip limits. This project involved the use of chevron traps, bottom longlines, and bandit gear to sample these species and utilize pre-existing data to model age/length at maturity and transition in order to determine the extent to which the reduction in catch limits may have impacted the life histories of either of these groupers. Since the data from ongoing sampling was not immediately available, pre-existing data on length, age, maturity, and sex transition stage from previously sampled fish were used to fit logistic models using iterative least squares for both age/length at maturity and transition for both species for the years prior to and following their respective regulatory change. The models for both species exhibited significantly different parameters before and after catch reductions and the results of this project provide insight into important changes in the life histories of these groupers over the past three decades