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1.
Front Mol Biosci ; 11: 1308202, 2024.
Article in English | MEDLINE | ID: mdl-38845778

ABSTRACT

Introduction: The global COVID-19 pandemic and seasonal influenza outbreaks have drawn attention to the critical need for accurate and efficient diagnostic tools. Methods: The performance of the InstaView COVID-19/Flu Ag Combo Test, which was designed to simultaneously detect the SARS-CoV-2, influenza A, and influenza B viruses, was analytically and clinically evaluated. Results: The InstaView COVID-19/Flu Ag Combo Test exhibited robust detection capabilities, accurately identifying SARS-CoV-2, influenza A, and influenza B viruses over a wide concentration range (1.41 × 103 to 7.05 × 104 TCID50/mL). Extensive testing against potential cross-reactants and interferences yielded no false-positive results, indicating the high specificity of the test. Clinical evaluation further confirmed the kit's reliability, with sensitivity ranging from 95.1% to 98.2% for SARS-CoV-2, 88.9%-95.2% for influenza A, and 91.7%-100% for influenza B depending on the sample type. The specificity was consistently 100% for all of the targeted viruses. Discussion: The InstaView COVID-19/Flu Ag Combo Test thus demonstrated high performance, ease of use, rapid results, and the ability to precisely detect SARS-CoV-2 and influenza A/B infections, making it an effective tool in streamlining diagnostic workflows, optimizing resource allocation, and improving patient outcomes.

2.
Cancers (Basel) ; 16(4)2024 Feb 08.
Article in English | MEDLINE | ID: mdl-38398103

ABSTRACT

Prostate cancer represents a significant health risk to aging men, in which diagnostic challenges to the identification of aggressive cancers remain unmet. Prostate cancer screening is driven by the prostate-specific antigen (PSA); however, in men with benign prostatic hyperplasia (BPH) due to an enlarged prostate and elevated PSA, PSA's screening utility is diminished, resulting in many unnecessary biopsies. To address this issue, we previously identified a cleaved fragment of Filamin A (FLNA) protein (as measured with IP-MRM mass spectrometry assessment as a prognostic biomarker for stratifying BPH from prostate cancer and subsequently evaluated its expanded utility in Caucasian (CA) and African American (AA) men. All men had a negative digital rectal examination (DRE) and PSA between 4 and 10 ng/mL and underwent prostate biopsy. In AA men, FLNA serum levels exhibited diagnostic utility for stratifying BPH from patients with aggressive prostate cancer (0.71 AUC and 12.2 OR in 48 men with BPH and 60 men with PCa) and outperformed PSA (0.50 AUC, 2.2 OR). In CA men, FLNA serum levels also exhibited diagnostic utility for stratifying BPH from patients with aggressive prostate cancer (0.74 AUC and 19.4 OR in 191 men with BPH and 109 men with PCa) and outperformed PSA (0.46 AUC, 0.32 OR). Herein, we established FLNA alone as a serum biomarker for stratifying men with BPH vs. those with high Gleason (7-10) prostate cancers compared to the current diagnostic paradigm of using PSA. This approach demonstrates clinical actionability of FLNA alone without the requirement of prostate volume measurement as a test with utility in AA and CA men and represents a significant opportunity to decrease the number of unnecessary biopsies in aggressive prostate cancer diagnoses.

3.
Drugs Real World Outcomes ; 9(3): 359-375, 2022 Sep.
Article in English | MEDLINE | ID: mdl-35809196

ABSTRACT

BACKGROUND: The COVID-19 pandemic generated a massive amount of clinical data, which potentially hold yet undiscovered answers related to COVID-19 morbidity, mortality, long-term effects, and therapeutic solutions. OBJECTIVES: The objectives of this study were (1) to identify novel predictors of COVID-19 any cause mortality by employing artificial intelligence analytics on real-world data through a hypothesis-agnostic approach and (2) to determine if these effects are maintained after adjusting for potential confounders and to what degree they are moderated by other variables. METHODS: A Bayesian statistics-based artificial intelligence data analytics tool (bAIcis®) within the Interrogative Biology® platform was used for Bayesian network learning and hypothesis generation to analyze 16,277 PCR+ patients from a database of 279,281 inpatients and outpatients tested for SARS-CoV-2 infection by antigen, antibody, or PCR methods during the first pandemic year in Central Florida. This approach generated Bayesian networks that enabled unbiased identification of significant predictors of any cause mortality for specific COVID-19 patient populations. These findings were further analyzed by logistic regression, regression by least absolute shrinkage and selection operator, and bootstrapping. RESULTS: We found that in the COVID-19 PCR+ patient cohort, early use of the antiemetic agent ondansetron was associated with decreased any cause mortality 30 days post-PCR+ testing in mechanically ventilated patients. CONCLUSIONS: The results demonstrate how a real-world COVID-19-focused data analysis using artificial intelligence can generate unexpected yet valid insights that could possibly support clinical decision making and minimize the future loss of lives and resources.

4.
Sci Rep ; 12(1): 1186, 2022 01 24.
Article in English | MEDLINE | ID: mdl-35075163

ABSTRACT

Cancer biomarker discovery is critically dependent on the integrity of biofluid and tissue samples acquired from study participants. Multi-omic profiling of candidate protein, lipid, and metabolite biomarkers is confounded by timing and fasting status of sample collection, participant demographics and treatment exposures of the study population. Contamination by hemoglobin, whether caused by hemolysis during sample preparation or underlying red cell fragility, contributes 0-10 g/L of extraneous protein to plasma, serum, and Buffy coat samples and may interfere with biomarker detection and validation. We analyzed 617 plasma, 701 serum, and 657 buffy coat samples from a 7-year longitudinal multi-omic biomarker discovery program evaluating 400+ participants with or at risk for pancreatic cancer, known as Project Survival. Hemolysis was undetectable in 93.1% of plasma and 95.0% of serum samples, whereas only 37.1% of buffy coat samples were free of contamination by hemoglobin. Regression analysis of multi-omic data demonstrated a statistically significant correlation between hemoglobin concentration and the resulting pattern of analyte detection and concentration. Although hemolysis had the greatest impact on identification and quantitation of the proteome, distinct differentials in metabolomics and lipidomics were also observed and correlated with severity. We conclude that quality control is vital to accurate detection of informative molecular differentials using OMIC technologies and that caution must be exercised to minimize the impact of hemolysis as a factor driving false discovery in large cancer biomarker studies.


Subject(s)
Biomarkers/blood , Hemolysis , Lipidomics/standards , Pancreatic Neoplasms/blood , Pancreatitis/blood , Proteomics/standards , Case-Control Studies , Female , Humans , Male , Mass Spectrometry , Precision Medicine
5.
J Clin Invest ; 131(19)2021 10 01.
Article in English | MEDLINE | ID: mdl-34411004

ABSTRACT

BACKGROUNDThe angiotensin-converting enzyme (ACE) D allele is more prevalent among African Americans compared with other races and ethnicities and has previously been associated with severe coronavirus disease 2019 (COVID-19) pathogenesis through excessive ACE1 activity. ACE inhibitors/angiotensin receptor blockers (ACE-I/ARB) may counteract this mechanism, but their association with COVID-19 outcomes has not been specifically tested in the African American population.METHODSWe identified 6218 patients who were admitted into Mount Sinai hospitals with COVID-19 between February 24 and May 31, 2020, in New York City. We evaluated whether the outpatient and in-hospital use of ACE-I/ARB is associated with COVID-19 in-hospital mortality in an African American compared with non-African American population.RESULTSOf the 6218 patients with COVID-19, 1138 (18.3%) were ACE-I/ARB users. In a multivariate logistic regression model, ACE-I/ARB use was independently associated with a reduced risk of in-hospital mortality in the entire population (OR, 0.655; 95% CI, 0.505-0.850; P = 0.001), African American population (OR, 0.44; 95% CI, 0.249-0.779; P = 0.005), and non-African American population (OR, 0.748, 95% CI, 0.553-1.012, P = 0.06). In the African American population, in-hospital use of ACE-I/ARB was associated with improved mortality (OR, 0.378; 95% CI, 0.188-0.766; P = 0.006), whereas outpatient use was not (OR, 0.889; 95% CI, 0.375-2.158; P = 0.812). When analyzing each medication class separately, ARB in-hospital use was significantly associated with reduced in-hospital mortality in the African American population (OR, 0.196; 95% CI, 0.074-0.516; P = 0.001), whereas ACE-I use was not associated with impact on mortality in any population.CONCLUSIONIn-hospital use of ARB was associated with a significant reduction in in-hospital mortality among COVID-19-positive African American patients.FUNDINGNone.


Subject(s)
Angiotensin Receptor Antagonists/administration & dosage , Angiotensin-Converting Enzyme Inhibitors/administration & dosage , Black or African American , COVID-19 Drug Treatment , COVID-19 , Hospital Mortality/ethnology , SARS-CoV-2/metabolism , Aged , COVID-19/ethnology , COVID-19/metabolism , COVID-19/mortality , Disease-Free Survival , Female , Humans , Male , Middle Aged , Peptidyl-Dipeptidase A/metabolism , Retrospective Studies , Survival Rate
6.
Sci Rep ; 11(1): 15052, 2021 07 23.
Article in English | MEDLINE | ID: mdl-34302010

ABSTRACT

Prostate-specific antigen (PSA) screening for prostate cancer (PCa) is limited by the lack of specificity but is further complicated in the benign prostatic hyperplasia (BPH) population which also exhibit elevated PSA, representing a clear unmet need to distinguish BPH from PCa. Herein, we evaluated the utility of FLNA IP-MRM, age, and prostate volume to stratify men with BPH from those with PCa. Diagnostic performance of the biomarker panel was better than PSA alone in discriminating patients with negative biopsy from those with PCa, as well as those who have had multiple prior biopsies (AUC 0.75 and 0.87 compared to AUC of PSA alone 0.55 and 0.57 for patients who have had single compared to multiple negative biopsies, respectively). Of interest, in patients with PCa, the panel demonstrated improved performance than PSA alone in those with Gleason scores of 5-7 (AUC 0.76 vs. 0.56) and Gleason scores of 8-10 (AUC 0.74 vs. 0.47). With Gleason scores (8-10), the negative predictive value of the panel is 0.97, indicating potential to limit false negatives in aggressive cancers. Together, these data demonstrate the ability of the biomarker panel to perform better than PSA alone in men with BPH, thus preventing unnecessary biopsies.


Subject(s)
Biomarkers, Tumor/blood , Diagnosis, Differential , Prostatic Hyperplasia/diagnosis , Prostatic Neoplasms/diagnosis , Aged , Humans , Male , Middle Aged , Neoplasm Grading , Prostate/metabolism , Prostate-Specific Antigen/blood , Prostatic Hyperplasia/blood , Prostatic Hyperplasia/pathology , Prostatic Neoplasms/blood , Prostatic Neoplasms/pathology
7.
Sci Rep ; 11(1): 5749, 2021 03 11.
Article in English | MEDLINE | ID: mdl-33707480

ABSTRACT

Reactive oxygen species (ROS) are implicated in triggering cell signalling events and pathways to promote and maintain tumorigenicity. Chemotherapy and radiation can induce ROS to elicit cell death allows for targeting ROS pathways for effective anti-cancer therapeutics. Coenzyme Q10 is a critical cofactor in the electron transport chain with complex biological functions that extend beyond mitochondrial respiration. This study demonstrates that delivery of oxidized Coenzyme Q10 (ubidecarenone) to increase mitochondrial Q-pool is associated with an increase in ROS generation, effectuating anti-cancer effects in a pancreatic cancer model. Consequent activation of cell death was observed in vitro in pancreatic cancer cells, and both human patient-derived organoids and tumour xenografts. The study is a first to demonstrate the effectiveness of oxidized ubidecarenone in targeting mitochondrial function resulting in an anti-cancer effect. Furthermore, these findings support the clinical development of proprietary formulation, BPM31510, for treatment of cancers with high ROS burden with potential sensitivity to ubidecarenone.


Subject(s)
Apoptosis , Mitochondria/metabolism , Pancreatic Neoplasms/pathology , Reactive Oxygen Species/metabolism , Ubiquinone/analogs & derivatives , Animals , Cell Line, Tumor , Cell Proliferation , Cell Respiration , Cell Survival , Electron Transport Complex II/metabolism , Glycerol-3-Phosphate Dehydrogenase (NAD+) , Humans , Membrane Potential, Mitochondrial , Mice, Nude , Organoids/pathology , Oxidative Stress , Oxygen Consumption , Pancreatic Neoplasms/metabolism , Substrate Specificity , Ubiquinone/metabolism
8.
J Racial Ethn Health Disparities ; 8(4): 973-980, 2021 08.
Article in English | MEDLINE | ID: mdl-32901433

ABSTRACT

RATIONALE: Hypertension, obesity and diabetes are major risk factors associated with morbidities underlying COVID-19 infections. Regression analysis correlated presence of ACE insertion/deletion (I/D) polymorphism to COVID-19 incidence and mortality. Furthermore, COVID-19 prevalence correlated to allele frequency of angiotensin-converting enzyme (ACE) deletion (D) polymorphism within the European population. OBJECTIVE: Homozygous ACE deletion polymorphism is associated with increase in ACE and angiotensin II (Ang-II), sustained levels can result in inflammation, fibrosis and organ damage. The ACE DD polymorphism is also associated with hypertension, acute respiratory distress and diabetic nephropathy, all considered high risk for COVID-19 infection and outcomes. The study objective was to describe a biological framework associating ethnic prevalence of ACE deletion polymorphism to COVID-19 comorbidities providing rationale for therapeutic utility of ACE-I/ARBs to improve outcomes. METHOD AND RESULTS: The Allele Frequency Database (ALFRED) was queried for frequency of rs4646994 representing ACE I/D polymorphism. In a total of 349 worldwide population samples, frequency of ACE D allele was higher in European, Asian, and Africans cohorts. In the USA, the frequency of ACE D allele was higher in non-Hispanic Black compared with non-Hispanic White and Mexican Americans. CONCLUSION: COVID-19 binding mediated reduction/inactivation of ACE-II can increase ACE/Ang-II signalling pathway and related pathologies. The presence of ACE DD polymorphism with COVID-19 infection likely augments ACE/Ang-II activities, increasing severity of COVID-19 morbidities and impacts outcomes. Thus, ethnic prevalence of ACE DD polymorphism can explain in part the severity of COVID-19 morbidity providing rationale for the use of ACE-I/ARBs to improve outcomes.


Subject(s)
COVID-19 Drug Treatment , COVID-19/ethnology , Ethnicity/genetics , Genetic Predisposition to Disease/ethnology , Peptidyl-Dipeptidase A/genetics , Angiotensin Receptor Antagonists/therapeutic use , Angiotensin-Converting Enzyme Inhibitors/therapeutic use , Humans , Polymorphism, Genetic , Prevalence , Risk Factors
9.
Breast Cancer Res Treat ; 186(1): 107-114, 2021 Feb.
Article in English | MEDLINE | ID: mdl-33206291

ABSTRACT

PURPOSE: Chemotherapy-induced alopecia (CIA) negatively affects psychosocial health and quality of life (QoL). Currently, there are no approved pharmacologic agents to prevent CIA. Here, we evaluated the safety, tolerability, and potential signal of efficacy of topical calcitriol (BPM31543) on CIA prevention. MATERIALS AND METHODS: This Phase 1 trial included 23 female patients with breast cancer, gynecologic cancer, or sarcomas receiving a taxane-based chemotherapy. Patients received a 3 + 3 dose-escalation regimen at 5, 10, 20, 40, 60, and 80 µg/mL, with 3-6 patients per group. Patients applied topical BPM31543 to the scalp twice a day for 2 weeks prior to chemotherapy and continued until chemotherapy treatment was completed. The maximum tolerated dose (MTD) during first 28 day application was determined. Adverse event (AE) monitoring, pharmacokinetics, blinded photographic assessments, and patient self-assessment were evaluated. RESULTS: Out of 23 patients treated with BPM31543, 8 patients experienced at least 1 treatment-related adverse event (AE). The majority of AEs were mild to moderate in severity. Only 1 patient experienced SAEs (vomiting, nausea, fever, and flank pain) considered treatment related. Alopecia < 50% from baseline was observed in 8 patients at Week 7, and, of which 2 patients had < 50% alopecia maintained at Week 15. There were no detectable effects of topical BPM31543 on serum levels of calcitriol. CONCLUSIONS: BPM31543 applied topically twice daily to the scalp is safe and well tolerated in patients receiving taxane-based chemotherapy. No DLT was observed at up to 80 µg/mL, and MTD was not reached. Based on the data from this trial, BPM31543 represents a promising therapy and warrants further investigation in Phase 2/3 trials.


Subject(s)
Antineoplastic Agents , Breast Neoplasms , Alopecia/chemically induced , Alopecia/prevention & control , Antineoplastic Agents/adverse effects , Breast Neoplasms/drug therapy , Calcitriol , Female , Humans , Quality of Life
10.
J Transl Med ; 18(1): 10, 2020 01 07.
Article in English | MEDLINE | ID: mdl-31910880

ABSTRACT

BACKGROUND: Predicting the clinical course of prostate cancer is challenging due to the wide biological spectrum of the disease. The objective of our study was to identify prostate cancer prognostic markers in patients 'sera using a multi-omics discovery platform. METHODS: Pre-surgical serum samples collected from a longitudinal, racially diverse, prostate cancer patient cohort (N = 382) were examined. Linear Regression and Bayesian computational approaches integrated with multi-omics, were used to select markers to predict biochemical recurrence (BCR). BCR-free survival was modeled using unadjusted Kaplan-Meier estimation curves and multivariable Cox proportional hazards analysis, adjusted for key pathologic variables. Receiver operating characteristic (ROC) curve statistics were used to examine the predictive value of markers in discriminating BCR events from non-events. The findings were further validated by creating a training set (N = 267) and testing set (N = 115) from the cohort. RESULTS: Among 382 patients, 72 (19%) experienced a BCR event in a median follow-up time of 6.9 years. Two proteins-Tenascin C (TNC) and Apolipoprotein A1V (Apo-AIV), one metabolite-1-Methyladenosine (1-MA) and one phospholipid molecular species phosphatidic acid (PA) 18:0-22:0 showed a cumulative predictive performance of AUC = 0.78 [OR (95% CI) = 6.56 (2.98-14.40), P < 0.05], in differentiating patients with and without BCR event. In the validation set all four metabolites consistently reproduced an equivalent performance with high negative predictive value (NPV; > 80%) for BCR. The combination of pTstage and Gleason score with the analytes, further increased the sensitivity [AUC = 0.89, 95% (CI) = 4.45-32.05, P < 0.05], with an increased NPV (0.96) and OR (12.4) for BCR. The panel of markers combined with the pathological parameters demonstrated a more accurate prediction of BCR than the pathological parameters alone in prostate cancer. CONCLUSIONS: In this study, a panel of serum analytes were identified that complemented pathologic patient features in predicting prostate cancer progression. This panel offers a new opportunity to complement current prognostic markers and to monitor the potential impact of primary treatment versus surveillance on patient oncological outcome.


Subject(s)
Prostatectomy , Prostatic Neoplasms , Bayes Theorem , Biomarkers , Disease Progression , Humans , Male , Neoplasm Grading , Neoplasm Recurrence, Local , Prognosis , Prostate-Specific Antigen , Prostatic Neoplasms/diagnosis , Prostatic Neoplasms/surgery
11.
Mil Med ; 183(9-10): e619-e623, 2018 09 01.
Article in English | MEDLINE | ID: mdl-29788356

ABSTRACT

BACKGROUND: Low back pain is a primary health care utilization driver in the US population. Health care evaluation visits for low back pain are as common as medical evaluation for the common cold. Low back pain is the most common reason for reductions in activities of daily living and work activity in the general population. Although these statistics are compelling, in the military population, there is arguably a significantly greater economic impact on the military population, as the cost to train, retain, and deploy a service member is a tremendous cost. METHODS: The current study retrospectively examines surgical outcomes, return to duty, and patient-centric outcomes among 82 active duty or reserve military patients who underwent an outpatient minimally invasive spine surgery Laminotomy Foraminotomy Decompression for the treatment of lumbar spinal stenosis in an ambulatory surgery center. FINDINGS: Overall, our results indicate that within the 82 active duty military service members, 100% of the service members return to duty within 3 mo. Additionally, there was a significant reduction in self-reported pain and disability 12 mo postoperative, whereas the average length of surgery was 62 min with an average estimated blood loss of 30.64 mL. DISCUSSION: The current study indicates that minimally invasive procedures for the treatment of lumbar spinal stenosis in an ambulatory surgery center setting are an effective option for active duty servicemen to reduce return-to-duty rates and symptomatic back-related pain and disability.


Subject(s)
Military Personnel/statistics & numerical data , Minimally Invasive Surgical Procedures/statistics & numerical data , Return to Work/statistics & numerical data , Adult , Ambulatory Surgical Procedures/methods , Ambulatory Surgical Procedures/statistics & numerical data , Female , Foraminotomy/methods , Foraminotomy/standards , Foraminotomy/statistics & numerical data , Humans , Laminectomy/methods , Laminectomy/standards , Laminectomy/statistics & numerical data , Male , Middle Aged , Minimally Invasive Surgical Procedures/methods , Orthopedic Procedures/methods , Orthopedic Procedures/statistics & numerical data , Pain/complications , Pain/etiology , Pain Measurement/methods , Postoperative Complications/diagnosis , Postoperative Complications/epidemiology , Retrospective Studies , Treatment Outcome
12.
Mil Med ; 175(8): 581-6, 2010 Aug.
Article in English | MEDLINE | ID: mdl-20731262

ABSTRACT

The Department of Defense (DoD) Military Health System (MHS) embodies decades of health care practice that has evolved in scope and complexity to meet the demands for quality care to which its beneficiaries are entitled. War, Base Realignment and Closure (BRAC), and other dynamic forces require the ongoing review and revision of health care policy and practice in military hospitals as well as the expanded network of civilian providers who care for our nation's soldiers, sailors, airmen, and marines and their families. The result has been an incrementally constructed quality assurance (QA) program with emphasis on organizational structures, programs, and systems, and the use of robust data sources and standard measures to analyze and improve processes, manage disease, assess patient perceptions of care, and ensure that a uniform health care benefit and high quality health care is accessible to all MHS beneficiaries.


Subject(s)
Government Agencies/history , Military Medicine/history , Quality Assurance, Health Care/history , Health Policy/history , Health Policy/trends , Health Services Accessibility/history , Health Services Accessibility/trends , History, 20th Century , History, 21st Century , Humans , Military Medicine/standards , Military Medicine/trends , Quality Assurance, Health Care/standards , Quality Assurance, Health Care/trends , United States
13.
Arch Pediatr Adolesc Med ; 164(8): 720-6, 2010 Aug.
Article in English | MEDLINE | ID: mdl-20530290

ABSTRACT

OBJECTIVE: To assess racial and ethnic differences in asthma prevalence, treatment patterns, and outcomes among a diverse population of children with equal access to health care. DESIGN: Retrospective cohort analysis. SETTING: The Military Health System. PARTICIPANTS: A total of 822 900 children aged 2 through 17 years continuously enrolled throughout 2007 in TRICARE Prime, a health maintenance organization-type benefit provided by the Department of Defense. MAIN OUTCOME MEASURES: Prevalence of diagnosed asthma, potentially avoidable asthma hospitalizations, asthma-related emergency department visits, visits to asthma specialists, and use of asthma medications among children aged 2 to 4, 5 to 10, and 11 to 17 years. RESULTS: Black and Hispanic children in all age groups were significantly more likely to have an asthma diagnosis than white children (ranging from odds ratio [OR]=1.16; 95% confidence interval [CI], 1.09-1.24; to OR=2.00; 95% CI, 1.93-2.07). Black children in all age groups and Hispanic children aged 5 to 10 years were significantly more likely to have any potentially avoidable asthma hospitalizations and asthma-related emergency department visits (ranging from OR=1.24; 95% CI, 1.11-1.37; to OR=1.99; 95% CI, 1.37-2.88) and were significantly less likely to visit a specialist (ranging from OR=0.71; 95% CI, 0.61-0.82; to OR=0.88; 95% CI, 0.79-0.98) compared with white children. Black children in all age categories were significantly more likely to have filled any prescriptions for inhaled corticosteroids compared with white children (ranging from OR=1.11; 95% CI, 1.02-1.21; to OR=1.11; 95% CI, 1.04-1.19). CONCLUSIONS: Despite universal health insurance coverage, we found evidence of racial and ethnic differences in asthma prevalence, treatment, and outcomes.


Subject(s)
Asthma/epidemiology , Asthma/therapy , Black or African American , Health Services Accessibility/statistics & numerical data , Health Status Disparities , Healthcare Disparities/statistics & numerical data , Hispanic or Latino , White People , Adolescent , Child , Child, Preschool , Cohort Studies , Female , Humans , Male , Military Personnel , Prevalence , Retrospective Studies , Treatment Outcome , United States
14.
Circ Cardiovasc Qual Outcomes ; 2(2): 108-15, 2009 Mar.
Article in English | MEDLINE | ID: mdl-20031822

ABSTRACT

BACKGROUND: Influenza infection has been associated with increased risk of adverse cardiac and cerebral vascular outcomes. Oseltamivir, a treatment for influenza, has been shown to decrease the severity of an influenza episode, but few data exist regarding its potentially protective effect against recurrent vascular outcomes among influenza patients with a history of vascular disease. METHODS AND RESULTS: Electronic healthcare service and pharmacy records for 37,482 TRICARE beneficiaries, aged 18 and older, with a coded history of cardiovascular (CV) disease and a subsequent diagnosis of influenza from October 1, 2003, through September 30, 2007, were examined. Subjects were grouped according to whether they had filled a prescription for oseltamivir within 2 days of their influenza diagnosis. The incidence of recurrent CV events within 30 days after the influenza diagnosis among oseltavmivir-treated and untreated subjects was 8.5% and 21.2%, respectively (P<0.005). Subject age was a persistent and significant contributor to the likelihood of recurrent CV outcomes. After controlling for the differences in demographics among treated and untreated cohorts using a propensity-scored logistic regression model, a statistically significant protective effect was associated with oseltamivir treatment (odds ratio, 0.417; 95% CI, 0.349 to 0.498). CONCLUSIONS: Our findings suggests that oseltamivir treatment for influenza is associated with significant decrease in the risk of recurrent CV events in subjects with a history of CV disease. These findings merit confirmation in further prospective and controlled studies. Meanwhile, in patients with CV disease, strict adherence with current practice guidelines for prevention and treatment of influenza is recommended.


Subject(s)
Antiviral Agents/therapeutic use , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/prevention & control , Influenza, Human/drug therapy , Influenza, Human/epidemiology , Oseltamivir/therapeutic use , Adult , Aged , Female , Follow-Up Studies , Humans , Incidence , Logistic Models , Male , Middle Aged , Military Personnel/statistics & numerical data , Multivariate Analysis , Risk Factors , Secondary Prevention , United States/epidemiology , United States Government Agencies/statistics & numerical data
15.
Pharmacoepidemiol Drug Saf ; 18(11): 1048-52, 2009 Nov.
Article in English | MEDLINE | ID: mdl-19655338

ABSTRACT

PURPOSE: To describe utilization patterns for anti-diabetes medications among a cohort of diabetes patients in the Military Health System (MHS) before and after warnings about rosiglitazone issued in May 2007. METHODS: We used segmented regression analysis to compare changes in the level and trend of rosiglitazone utilization and use of other anti-diabetes therapies in the period prior to the drug warnings (between April 2006 and May 2007) and the period after the warnings were issued (between October 2007 and May 2008). RESULTS: The level and trend of rosiglitazone use changed after the highly publicized warnings. The number of prescriptions filled fell by almost 7000 after the warning (p < 0.001). The number of prescriptions filled for pioglitazone, sulfonylureas, and other diabetes drugs increased significantly after the warnings (p < 0.05 in all models). Overall, the level and trend of filled prescriptions per month for all anti-diabetic drugs did not significantly change after the warnings. CONCLUSIONS: Utilization patterns changed in response to warnings about rosiglitazone. While overall utilization of anti-diabetic drugs did not change, further study is needed to determine the associated health outcomes.


Subject(s)
Drug Utilization Review/trends , Hypoglycemic Agents/administration & dosage , Hypoglycemic Agents/adverse effects , Military Personnel , Thiazolidinediones/administration & dosage , Thiazolidinediones/adverse effects , Drug Prescriptions/statistics & numerical data , Humans , Insurance Claim Review , Insurance, Pharmaceutical Services/statistics & numerical data , Military Personnel/statistics & numerical data , Rosiglitazone , United States , United States Food and Drug Administration
16.
J Natl Med Assoc ; 101(7): 663-70, 2009 Jul.
Article in English | MEDLINE | ID: mdl-19634587

ABSTRACT

BACKGROUND: As a major provider of health care for racial and ethnic minority groups, the federal government has affirmed its commitment to the elimination of health disparities. Although numerous studies have examined health care disparities in various federal systems of care, few have examined these issues within TRICARE, the Department of Defense (DoDJ's program for providing health care coverage to members of the uniformed services and their dependents. METHODS: This study provides an exploratory analysis examining apparent disparities in health status, access to and satisfaction with care, and use of preventive care using the 2007 Health Care Survey of DoD Beneficiaries. Analyses compare outcomes by race/ethnicity and between TRICARE beneficiaries and national norms derived from the National Consumer Assessment of Health Plans Study Benchmarking Database and the National Healthcare Disparities Report, and are stratified by duty status. RESULTS: Compared to black non-Hispanics, a higher proportion of white non-Hispanic active-duty and retiree TRICARE beneficiaries reported good to excellent health status. However, on most measures, we found no differences between white non-Hispanic beneficiaries and members of racial/ethnic groups. When differences did exist, minority populations were likely to report better access to and use of services than whites. CONCLUSIONS: Although health disparities exist in health status and some measures of preventive care, black non-Hispanics and Hispanics often receive more equitable care under TRICARE than in the nation as a whole. These findings suggest the need to explore the characteristics of TRICARE that may be associated with more-favorable outcomes for racial and ethnic minority groups.


Subject(s)
Black or African American/statistics & numerical data , Healthcare Disparities , Insurance, Health , Military Personnel , White People/statistics & numerical data , Adolescent , Adult , Aged , Family , Female , Health Status , Humans , Male , Middle Aged , United States , Veterans/statistics & numerical data
18.
Cancer Epidemiol Biomarkers Prev ; 18(6): 1740-5, 2009 Jun.
Article in English | MEDLINE | ID: mdl-19505907

ABSTRACT

The U.S. active-duty military population may differ from the U.S. general population in its exposure to cancer risk factors and access to medical care. Yet, it is not known if cancer incidence rates differ between these two populations. We therefore compared the incidence of four cancers common in U.S. adults (lung, colorectal, prostate, and breast cancers) and two cancers more common in U.S. young adults (testicular and cervical cancers) in the military and general populations. Data from the Automated Central Tumor Registry (ACTUR) of the Department of Defense and the nine cancer registries of the Surveillance, Epidemiology and End Results (SEER) of the National Cancer Institute for the years 1990 to 2004 for persons with ages 20 to 59 years were analyzed. Incidence rates were significantly lower in the military population for colorectal cancer in White men, lung cancer in White and Black men and White women, and cervical cancer in Black women. In contrast, incidence rates of breast and prostate cancers were significantly higher in the military among Whites and Blacks. Incidence rates of testicular cancer did not differ between ACTUR and SEER. Although the numbers of diagnoses among military personnel were relatively small for temporal trend analysis, we found a more prominent increase in prostate cancer in ACTUR than in SEER. Overall, these results suggest that cancer patterns may differ between military and nonmilitary populations. Further studies are needed to confirm these findings and explore contributing factors.


Subject(s)
Military Personnel/statistics & numerical data , Neoplasms/epidemiology , Adult , Female , Humans , Incidence , Male , Middle Aged , SEER Program , United States
19.
Int J Adolesc Med Health ; 21(1): 79-89, 2009.
Article in English | MEDLINE | ID: mdl-19526698

ABSTRACT

UNLABELLED: Recent reports out of Japan have linked therapeutic use of the oral neuraminidase inhibitor oseltamivir with adverse neuropsychiatric outcomes in adolescents. OBJECTIVE: To assess if protective measures should be taken to mitigate potential adverse outcomes among United States Department of Defense (DoD) pediatric beneficiaries who are prescribed oseltamivir therapeutically. STUDY GROUP: DoD healthcare beneficiaries, ages 1 through 21 years, who received a diagnosis of influenza from 1 October 2006 through 30 September 2007. METHODS: A retrospective cohort study using electronic healthcare service and pharmacy fill. Cross tabulations and propensity-adjusted logistic regression analyses were performed to compare the frequency of adverse neuropsychiatric outcomes among those treated therapeutically with oseltamivir with those that were not. RESULTS: The prevalences of neuropsychiatric diagnoses following the influenza diagnosis overall and among the treated and untreated groups were 3.5%, 3.0%, and 3.8%, respectively (p < .05). A statistically significant protective effect was associated with oseltamivir treatment (prevalence odds ratio (POR) = 0.82 (95% CI, 0.69, 0.96)) in a propensity-adjusted regression model. The model significantly associated increasing patient age with the likelihood of an adverse neuropsychiatric outcome, but the associations with patient gender and parental rank, a proxy used for socioeconomic status, were not statistically Significant. CONCLUSIONS: Our retrospective study found no evidence that oseltamivir treatment for influenza increased the risk of adverse neuropsychiatric outcomes among the study population. An additional study focusing on prospective medical surveillance of influenza patients is warranted.


Subject(s)
Antiviral Agents/adverse effects , Influenza, Human/drug therapy , Nervous System Diseases/chemically induced , Oseltamivir/adverse effects , Psychoses, Substance-Induced , Adolescent , Adult , Antiviral Agents/therapeutic use , Child , Child Welfare , Child, Preschool , Confidence Intervals , Female , Humans , Infant , Logistic Models , Male , Multivariate Analysis , Odds Ratio , Oseltamivir/therapeutic use , Psychometrics , Retrospective Studies , Risk Factors , Treatment Outcome , Young Adult
20.
Mil Med ; 174(3): 236-40, 2009 Mar.
Article in English | MEDLINE | ID: mdl-19354085

ABSTRACT

UNLABELLED: This report summarizes findings from the TRICARE Management Activity (TMA) Healthcare Facility Evidence-Based Design Survey. TMA conducted 382 telephone interviews with active duty (AD) personnel and 36 interviews with AD spouses to solicit their opinions regarding 10 proposed healthcare facility design features that could improve the comfort and convenience of a hospital stay. The survey was composed of 10 multiple-choice questions that were based on recent findings in evidence-based healthcare facility design features. RESULTS: The 4 most important features for all respondents include having space in the patient room for overnight visitors, privacy features, and individual control of lighting and temperature. CONCLUSION: Developing specific hospital design plans will likely require continuing to work with patients and their loved ones to develop well-defined requirements. Potential study techniques include interviewing in facilities, holding focus groups, and observing patient and family behavior in the facility.


Subject(s)
Evidence-Based Medicine , Health Facility Environment , Hospitals, Military/organization & administration , Military Medicine/organization & administration , Military Personnel/statistics & numerical data , Quality of Health Care/standards , Adolescent , Adult , Female , Health Care Surveys , Hospital Design and Construction , Humans , Iraq War, 2003-2011 , Male , Surveys and Questionnaires , United States , Young Adult
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