Miscellaneous diagnostic tests Archives - MPR Mon, 29 Apr 2024 20:30:30 +0000 en-US hourly 1 https://wordpress.org/?v=6.4.3 https://www.empr.com/wp-content/uploads/sites/7/2023/03/cropped-empr-32x32.jpg Miscellaneous diagnostic tests Archives - MPR 32 32 AACR: At-Home HPV Testing Boosts Cervical Cancer Screening Participation https://www.empr.com/home/news/aacr-at-home-hpv-testing-boosts-cervical-cancer-screening-participation/ Mon, 15 Apr 2024 13:00:00 +0000 https://www.empr.com/?p=218673 Combining self-sampling with phone-based patient navigation further increases screening participation.

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HealthDay News — Mailed at-home self-sampling for human papillomavirus (HPV) testing increases cervical cancer screening participation in underscreened populations by almost threefold, according to a study presented at the annual meeting of the American Association for Cancer Research, held from April 5 to 10 in San Diego.

Jane R. Montealegre, PhD, from the University of Texas MD Anderson Cancer Center in Houston, and colleagues evaluated the effectiveness of mailed at-home self-sampling for HPV testing in a safety-net health system setting. The analysis included data from 2115 patients who were randomly assigned to one of the 3 following arms: telephone recall to provider-performed screening (usual care; arm 1); telephone recall + mailed self-sampling kit for HPV testing (arm 2); or telephone recall + mailed self-sampling kit + telephone-based patient navigation (arm 3).

The researchers found that among participants, the median time since last screening test was 9.5 years. Screening participation across arms 1, 2, and 3 was 15.3, 44.0, and 51.4%, respectively. Compared with usual care (arm 1), the relative incidence of screening in arms 2 and 3 was 2.90 and 3.36, respectively. For arm 3 vs arm 2, the relative incidence of screening was 1.16.

“After US Food and Drug Administration approval, self-sampling for high-risk-HPV testing has the potential to dramatically increase participation in cervical cancer screening in underserved populations,” the authors write.

Abstract

More Information

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ACP: Screening Average-Risk Adults for Colorectal Cancer Should Start at 50 Years https://www.empr.com/home/news/acp-screening-average-risk-adults-for-colorectal-cancer-should-start-at-50-years/ Tue, 01 Aug 2023 13:00:00 +0000 https://www.empr.com/?p=201513

For asymptomatic average-risk adults, clinicians should consider not screening at age 45 to 49 years, according to ACP.

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HealthDay News — For asymptomatic average-risk patients, clinicians should start screening for colorectal cancer (CRC) at age 50 years, according to updated guidance from the American College of Physicians (ACP) published online August 1 in the Annals of Internal Medicine.

Amir Qaseem, MD, PhD, from ACP in Philadelphia, and colleagues developed updated guidance for clinicians on screening for CRC in asymptomatic average-risk adults.

The guidance statement included four recommendation statements. In asymptomatic average-risk adults, clinicians should start CRC screening at age 50 years. For average-risk adults aged 45 to 49 years, clinicians should consider not screening and should discuss the uncertainty relating to benefits and harms for this population. In asymptomatic average-risk adults older than 75 years or in asymptomatic average-risk adults with a life expectancy of 10 years or less, clinicians should stop screening for CRC. Selection of a screening test for CRC should be performed by clinicians in consultation with patients based on discussion of the benefits, harms, costs, availability, and frequency and considering patient values and preferences. Selection of a screening test should be between a fecal immunochemical or high-sensitivity guaiac fecal occult blood test every two years, colonoscopy every 10 years, or flexible sigmoidoscopy every 10 years plus a fecal immunochemical test every 2 years. Stool DNA, computed tomography (CT) colonography, capsule endoscopy, urine, or serum screening tests should not be used for CRC.

“The updated guidance statement from ACP advocates for reserving screening recommendations for tests and patient populations associated with favorable high-quality benefit-harm assessments. It shifts away from the more-testing-to-more-people approach in other U.S. guidelines,” write the authors of an accompanying editorial.

“The ACP guidance against CT colonography use to screen for CRC represents a step backward, particularly in underserved communities where screening rates are lower and CRC death rates are much higher,” the American College of Radiology wrote in a statement, adding that starting routine screening at age 50 years rather than 45 years “may also hinder recent gains against the nation’s third leading cancer killer. About a third of those who should be screened for CRC can’t or won’t get a colonoscopy. We need more testing options, not fewer.”

Guidance Statement From the American College of Physicians

Editorial (subscription or payment may be required)

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ACTHREL https://www.empr.com/drug/acthrel/ Thu, 22 Jul 2021 11:19:33 +0000 https://www.empr.com/drug/acthrel/ AI Model Can Predict Mortality in Community-Acquired Pneumonia https://www.empr.com/home/news/ai-model-can-predict-mortality-in-community-acquired-pneumonia/ Fri, 23 Jun 2023 13:44:04 +0000 https://www.empr.com/?p=199081 lung x-ray

Combination of deep learning model and established CURB-65 score yielded an increase in AUC for two validation cohorts.

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lung x-ray

HealthDay News — For patients with community-acquired pneumonia (CAP), a deep learning (DL) model using initial chest radiographs can predict 30-day mortality, according to a study published online June 14 in the American Journal of Roentgenology.

Changi Kim, from Seoul National University Hospital in South Korea, and colleagues developed a DL model to predict 30-day mortality in patients with CAP using chest radiographs from the time of diagnosis from 7105 patients from one institution. The model was evaluated in patients diagnosed with CAP during emergency department visits from the same institution (temporal test model [947 patients]) and from 2 additional different institutions (external test cohorts A and B [467 and 381 patients, respectively]).

The researchers found that in the temporal test set, the area under the receiver operating characteristic curve (AUC) for predicting 30-day mortality was higher for the DL model than the established risk prediction CURB-65 score (0.77 vs 0.67, respectively); in external test cohorts A and B, the higher AUC for the DL model was not significant compared with CURB-65 (0.80 vs 0.73 and 0.80 versus 0.72, respectively). In the 3 cohorts, the DL model exhibited significantly higher specificity (range, 61 to 69 vs 44 to 58%, respectively) at the same sensitivity achieved by the CURB-65 score. Compared with the CURB-65 score, combination of the DL model and CURB-65 score yielded an increase in AUC in the temporal test cohort and external test cohort B (0.77 and 0.80, respectively).

“The DL model may guide clinical decision-making in the management of patients with CAP by identifying high-risk patients who warrant hospitalization and intensive treatment,” the authors write.

Two authors disclosed financial ties to Lunit.

Abstract/Full Text (subscription or payment may be required)

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Artificial Intelligence Models Improve Clinicians’ Diagnostic Accuracy https://www.empr.com/home/news/artificial-intelligence-models-improve-clinicians-diagnostic-accuracy/ Wed, 20 Dec 2023 14:00:00 +0000 https://www.empr.com/?p=212798 Standard AI models improve predictions, but systematically biased predictions reduce accuracy.

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HealthDay News — Standard artificial intelligence (AI) models improve diagnostic accuracy, but systematically biased AI models reduce this accuracy, according to a study published in the Dececember 19 issue of the Journal of the American Medical Association.

Sarah Jabbour, from the University of Michigan in Ann Arbor, and colleagues examined the impact of systematically biased AI on clinician diagnostic accuracy in a randomized clinical vignette survey study. Clinicians were shown 9 clinical vignettes of patients hospitalized with acute respiratory failure and were asked to determine the likelihood of pneumonia, heart failure, or chronic obstructive pulmonary disease as the underlying cause. Clinicians were shown 2 vignettes without AI model input to establish baseline diagnostic accuracy and were then randomly assigned to see 6 vignettes with AI model input: three standard-model predictions and 3 systematically biased model predictions.

Overall, 457 clinicians were randomly assigned: 231 and 226 to AI model predictions without and with explanations, respectively. The researchers found that for the three diagnoses, clinicians’ baseline diagnostic accuracy was 73.0%. Clinician accuracy increased over baseline by 2.9 and 4.4 percentage points when shown a standard AI model without and with explanations. Clinician accuracy was reduced by 11.3 percentage points with systematically biased AI model predictions compared with baseline; providing biased AI model predictions with explanations reduced accuracy by 9.1 percentage points, representing a nonsignificant improvement of 2.3 percentage points compared with the systematically biased model.

“Although the findings of the study suggest that clinicians may not be able to serve as a backstop against flawed AI, they can play an essential role in understanding AI’s limitations,” the authors write.

One author reported receiving royalties from a patent from Airstrip.

Abstract/Full Text (subscription or payment may be required)

Editorial (subscription or payment may be required)

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Autism Can Be Predicted From Routine Developmental Surveillance Data https://www.empr.com/home/news/autism-can-be-predicted-from-routine-developmental-surveillance-data/ Tue, 16 Jan 2024 14:00:00 +0000 https://www.empr.com/?p=213909 Accuracy from combined measures of developmental milestone assessments plus demographics, single-visit assessment surpassed M-CHAT

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HealthDay News — Autism spectrum disorder (ASD) can be predicted from routine developmental surveillance data, according to a study published online January 10 in JAMA Network Open.

Guy Amit, PhD, from the KI Research Institute in Kfar Malal, Israel, and colleagues conducted a retrospective cohort study using nationwide data of developmental assessments conducted between January 1, 2014, and January 17, 2023, to develop predictive models for ASD. The study included all 1,187,397 children who were assessed at the maternal child health clinics that perform routine developmental surveillance of children from birth to 6 years of age.

The researchers found that the ASD prediction models performance improved with prediction age, with fair accuracy at 12 months of age. An area under the receiver operating characteristic curve of 0.83 was achieved, with sensitivity of 45.1% at 95.0% specificity using a model combining longitudinal measures of developmental milestone assessments with a minimal set of demographic variables, applied at 18 to 24 months of age. An area under the receiver operating characteristic curve of 0.81 was achieved using a model with single-visit assessments, with sensitivity of 41.2% at 95.0% specificity. The best performing models surpassed the pooled performance of Modified Checklist for Autism in Toddlers, which had sensitivity of 40% and 95.0% specificity.

“This study’s findings suggest that with the use of prediction models, ASD screening can be seamlessly integrated into routine early childhood developmental surveillance,” the authors write. “The suggested approach may assist children in receiving timely interventions and achieving their developmental potential.”

One author disclosed being a shareholder in LinkCaring Ltd.

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AZO TEST STRIPS https://www.empr.com/drug/azo-test-strips/ Thu, 22 Jul 2021 11:17:22 +0000 https://www.empr.com/drug/azo-test-strips/ Barriers to Mammogram Use Include Adverse Social Demographics https://www.empr.com/home/news/barriers-to-mammogram-use-include-adverse-social-demographics/ Fri, 12 Apr 2024 13:00:00 +0000 https://www.empr.com/?p=218651 Lower prevalence of mammogram seen for women with three or more versus no adverse social determinants of health, health-related social needs

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HealthDay News — Among women aged 50 to 74 years, specific adverse social determinants of health (SDOH) and health-related social needs (HRSNs) are associated with not having had a mammogram in the past 2 years, according to research published in the April 9 early-release issue of the US Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report.

Jacqueline W. Miller, MD, from the CDC in Atlanta, and colleagues estimated the prevalence of mammography use within the previous 2 years among women aged 40 to 74 years using data from the 2022 Behavioral Risk Factor Surveillance System.

The researchers found that state-level mammography use varied from 64.0 to 85.5% among women aged 50 to 74 years. There was an association noted for having health insurance and a personal health care provider with having had a mammogram within the previous 2 years. Mammography prevalence was 83.2 and 65.7% for those with no adverse SDOH and HRSNs and for those with 3 or more adverse SDOH and HRSNs, respectively, among women aged 50 to 74 years. Strong associations with not having had a mammogram within the previous 2 years were seen for life dissatisfaction, feeling socially isolated, experiencing lost or reduced hours of employment, receiving food stamps, lacking reliable transportation, and reporting cost as a barrier for access to care.

“Health care facilities, providers, and public health programs could consider developing policies and effective practices to conduct risk assessments for adverse SDOH and HRSNs and address SDOH and HRSNs such as cost to access health care, social isolation, lack of reliable transportation, and food insecurity,” the authors write.

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Blood Glucose Meter Comparisons https://www.empr.com/charts/blood-glucose-meter-comparisons/ Mon, 19 Nov 2012 19:00:00 +0000 https://www.empr.com/uncategorized/blood-glucose-meter-comparisons/ #articleColumn table.wkm ul li{padding: 0 0 10px 1em;}#articleColumn table.wkm p{ margin-bottom: 0;line-height: 120%;}.wkm-div {overflow: auto; }.wkm-SeeOnPhone { display: none; }thead.wkm {font-family: "Frutiger", "Verdana", "Helvetica", "Arial", sans-serif !important; font-weight: bold !important; font-size: 12px !important; font-style: normal; background-color: #D3DFE5; margin-top: 0; margin-bottom: 0; vertical-align: bottom; }tbody.wkm {font-family: "Frutiger", "Verdana", "Helvetica", "Arial", sans-serif; font-size: 12px!important; font-weight: normal!important; font-style: normal!important; line-height: 120% !important; text-align: left!important; background-color: #F4F7F8!important; margin-top: 0!important; margin-bottom: 0!important; vertical-align: top!important; }tfoot.wkm {font-family: "Frutiger", "Verdana", "Helvetica", "Arial", sans-serif; 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text-align: left; } Blood Glucose Meter Comparisons
BLOOD GLUCOSE METER COMPARISONS
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Battery Features
ABBOTT LABS • 888-522-5226 • myfreestyle.com
FreeStyle Freedom
Lite
1, 3, 6 0.3 20−500 5 no coding 400 3V • Small design • 4 programmable alarms • Connects to management software • Calculates 7‑, 14‑, 30‑day averages • Large display
FreeStyle Lite 1, 3, 6 0.3 20−500 5 no coding 400 3V  Small design  Backlit display  Test strip port light  4 programmable alarms  Connects to management software  Calculates 7-, 14-, 30-day averages
FreeStyle Precision Neo 1 0.6 20−500 5 no coding 1000 3V  Slim, ultra-lightweight design  Large display
 e-ink screen  Electronic logbook  OTC test strips  Connects to management software  Calculates 7-, 14, 30-day averages
ARKRAY • 800-818-8877 • arkrayusa.com
Glucocard Expression 1, 2, 3 0.5 20–600 6 automatic 300 AAA  Large display  3 programmable alarms  Bilingual voice features  Calculates 7-, 14-, 30-day averages
Glucocard Shine 1, 2, 3, 4, 5 0.5 20–600 5 automatic 500 3V  Compact design  Reverse LCD display  Backlit screen  Calculates 1-, 7-, 14-, 30-, 90-day averages
Glucocard Shine Connex 1, 2, 3, 4, 5 0.5 20–600 5 automatic 1000 3V  Large display  Bluetooth communication  Backlit screen  Calculates 1-, 7-, 14-, 30-, 90-day averages
Glucocard Shine Express 1, 2, 3, 4, 5 0.5 20–600 5 automatic 1000 AAA  Large display  29 different voice prompts  English or Spanish results  Backlit screen Calculates 1-, 7-, 14-, 30-, 90-day averages
Glucocard Shine XL 1, 2, 3, 4, 5 0.5 20–600 5 automatic 250 3V  Large display  Ergonomic design  Backlit screen Calculates 1-, 7-, 14-, 30-, 90-day averages
Glucocard Vital 1, 3 0.5 20–600 7 automatic 250 3V  Calculates 14-, 30-day averages
ASCENSIA DIABETES CARE • 800-348-8100 • ascensiadiabetes.com
Contour Next 1, 3 0.6 20−600 5 no coding 800 3V  Simple on-screen messages  Allows for applying more blood to sample  Multiple evaluations of single sample  Autolog with pre/post meal markers  14 languages  Calculates 7-, 14-, 30-, 90-day averages
Contour Next EZ 1 0.6 20−600 5 no coding 480 3V  Multiple evaluations of single sample  Allows for applying more blood to sample  Basic and Advanced Modes  Glucose sensor technology  Calculates 7-, 14-, 30-day averages
Contour Next Gen 1 0.6 20−600 5 no coding 800 3V  Large display  Wireless communication to Contour Diabetes app  smartLIGHT blood glucose target indicator  Allows for applying more blood to sample  Calculates 7-, 14-, 30-, 90-day averages
Contour Next Link 2.4 1, 3 0.6 20−600 5 no coding 1000 rechargeable lithium polymer battery, 3.4v-4.2v  Wireless communication to MiniMed 630G pump and 670G systems  Fasting and pre/post meal markers with alarm  Electronic logbook  Connects to CareLink software  Charge via USB  Allows for applying more blood to sample  Calculates 7-, 14-, 30-, 90-day averages
Contour Next One 1, 3 0.6 20−600 5 no coding 800 3V  Wireless communication to Contour Diabetes app  Fasting and pre/post meal markers  smartLIGHT blood glucose target indicator  Electronic logbook  Allows for applying more blood to sample
Contour Next USB 1, 3 0.6 20−600 5 no coding 2000 rechargeable lithium polymer battery, 3.4v-4.2v  Plug & Play USB  Multiple evaluations of single sample  Fasting and pre/post meal markers with alarm  Electronic logbook  Charge via USB  Allows for applying more blood to sample  Built-in GLUCOFACTS Deluxe software  Calculates 7-, 14-, 30-, 90-day averages
GE HEALTHCARE/BIONIME • 888-481-8485 • bionimeusa.com
GE333 1, 2, 3 0.75 10−600 5 automatic 500 AAA  Large backlit screen  True Auto Coding  Top loading  Pre/post meal markers  Bluetooth communication  Calculates 1-, 7-, 14-, 30-, 60-, 90-day averages
GE100 1, 2, 3 0.75 10−600 5 automatic 500 3V  Large screen  True Auto Coding  Top loading  Calculates 1-, 7-, 14-, 30-, 90-day averages
LIFESCAN • 800-227-8862 • onetouch.com
OneTouch Ultra2 1, 2, 3 1 20−600 5 button 500 3V • Records before and after meal results • Calculates 7‑, 14‑, 30‑day averages • Connects to diabetes management software
OneTouch Ultra Plus Flex 1 0.4 20−600 5 no coding 500 3V  Wireless or USB communication to OneTouch Reveal app  ColorSure range indicator
OneTouch Verio Flex 1 0.4 20−600 5 no coding 500 3V  Large color screen  ColorSure Range indicator
 Wireless communication to OneTouch Reveal app
OneTouch Verio Reflect 1 0.4 20−600 5 no coding 750 3V  ColorSure range indicator  Blood Sugar Mentor provides personalized guidance, insight and encouragement to manage highs and lows  Wireless communication to OneTouch Reveal app
NOVA DIABETES CARE • (800) 681-7390 • novacares.com
Nova Max Link 1, 2, 3 0.3 20−600 5 no coding 400 3V  Connects to Medtronic insulin pumps  Calculates 1-, 7-, 14-, 30-day averages
Nova Max Plus 1, 2, 3 0.3 20−600 5 no coding 400 3V  Test ketones  Calculates 1-, 7-, 14-, 30-day averages
PRODIGY DIABETES CARE • 800-243-2636 • prodigymeter.com
Prodigy Autocode 1, 2, 3, 4, 5, 6 0.7 20−600 7 no coding 450 AAA  Small design  4 languages  Connects to diabetes management software  Calculates 7-, 14-, 28-day averages
Prodigy Pocket 1, 2, 3, 4, 5, 6 0.7 20−600 7 no coding 120 3V  Small, lightweight design  Calculates 7-, 14-, 28-day averages  4 color schemes
Prodigy Voice 1, 2, 3, 4, 5, 6 0.7 20−600 7 no coding 450 AAA  Small design  Fully audible  Connects to diabetes management software  Calculates 7-, 14-, 21-, 30-, 60-, 90-day averages
ROCHE DIAGNOSTICS • 800-858-8072 • accu-chek.com
Accu-Chek Aviva* 1, 2, 3, 6 0.6 10−600 5 no coding 500 3V  Large display  Large area to place sample  Autolog with pre/post meal markers  4 programmable alarms  Ergonomic design with rubber grips  Calculates 7-, 14-, 30-, 90-day averages
Accu-Chek Guide 1, 3, 6 0.6 20–600 4 no coding 720 3V  Backlit display  Strip port light  Autolog with fasting and pre/post meal markers  Wireless connectivity with smartphone  4 programmable alarms  Strip release button  Calculates 7-, 14-, 30-, 90-day averages
Accu-Chek Guide Link 1, 3, 6 0.6 20–600 4 no coding 720 3V  Wireless bluetooth connectivity with Medtronic Minimed 770G hybrid pump  Backlit display  Strip port light  7-, 14-, 30-, 90-day averages
Accu-Chek Guide Me 1, 3, 6 0.6 20−600 4 no coding 720 3V  Simple design  Large LCD display  Allows for small blood sample anywhere along the strip end  Bluetooth and micro USB connectivity  Autologs to mySugr app on smartphone  Calculates 7-, 14-, 30-, 90-day averages
Accu-Chek Nano* 1,3 0.6 20–600 5 no coding 500 3V  Small design  Backlit display  4 programmable reminders  Autolog with pre/post meal markers  11 depth settings  Calculates 7-, 14-, 30-, 90-day averages
TRIVIDIA HEALTH • (800)-803-6025 • trividiahealth.com
Sidekick 1, 2 1 20–600 10 no coding 50 N/A  All-in-one system designed to look like vial of test strips (meter + test strip vial is a single unit)  Disposable
TRUE FOCUS 1, 2 0.4 20–600 4 no coding 400 3V  Calculates 1-, 7-, 14-, 30-day averages  Keytone test reminder
TRUE METRIX 1, 2 0.5 20–600 4 no coding 500 3V  4 programmable alarms  Audible fill detection  Ketone test reminder  Event tags (exercise, sickness, medication)  Strip release button  Calculates 7-, 14-, 30-day averages
TRUE METRIX AIR 1, 2 0.5 20–600 4 no coding 1000 3V  Wireless connectivity  4 programmable alarms  Audible fill detection  Ketone test reminder  Event tags (exercise, sickness, medication)  Strip release button  Calculates 7-, 14-, 30-, 60-, 90-day averages
TRUE METRIX GO 1 0.5 20–600 4 no coding 500 3V  Compact design  Calculates 7-, 14-, 30-day averages
NOTES

1 = Fingertips
2 = Forearm
3 = Thumb/palm (base of thumb or region under the pinky)
4 = Thigh
5 = Calf
6 = Upper arm
7 = Abdomen

*Meter is no longer manufactured but test strips are still available for purchase.

Not an inclusive list of products or medical devices. Please contact company for full product information.

(Rev. 1/2023)

]]>
Blood Glucose Meter Compatibility with Test Strips https://www.empr.com/charts/blood-glucose-meter-compatibility-with-test-strips/ Mon, 19 Nov 2012 16:00:00 +0000 https://www.empr.com/uncategorized/blood-glucose-meter-compatibility-with-test-strips/ #articleColumn table.wkm ul li{padding: 0 0 10px 1em;}#articleColumn table.wkm p{ margin-bottom: 0;line-height: 120%;}.wkm-div {overflow: auto; }.wkm-SeeOnPhone { display: none; }thead.wkm {font-family: "Frutiger", "Verdana", "Helvetica", "Arial", sans-serif !important; font-weight: bold !important; font-size: 12px !important; font-style: normal; background-color: #D3DFE5; margin-top: 0; margin-bottom: 0; vertical-align: bottom; }tbody.wkm {font-family: "Frutiger", "Verdana", "Helvetica", "Arial", sans-serif; font-size: 12px!important; font-weight: normal!important; font-style: normal!important; line-height: 120% !important; text-align: left!important; background-color: #F4F7F8!important; margin-top: 0!important; margin-bottom: 0!important; vertical-align: top!important; }tfoot.wkm {font-family: "Frutiger", "Verdana", "Helvetica", "Arial", sans-serif; font-size: 11px!important; font-weight: normal!important; font-style: normal!important; line-height: 120% !important; text-align: left; background-color: #F4F7F8; margin-top: 0; margin-bottom: 0; vertical-align: top; }p.wkm-hang { margin-top: 0!important; margin-bottom: 0!important; margin-left: 1em!important; text-indent: -1em!important; }th.wkm-intro {font-family: "Frutiger", "Verdana", "Helvetica", "Arial", sans-serif; font-weight: normal; font-size: 12px; font-style: normal; vertical-align: bottom; text-align: left; line-height: 120% ; background-color: white; border: none; border-collapse: collapse; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; margin-top: 0; margin-bottom: 0; }.wkm-spannerlvl1left {font-family: "Frutiger", "Verdana", "Helvetica", "Arial", sans-serif; font-weight: bolder; font-size: 12px; line-height: 120% ; text-transform: uppercase ; border: none; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; background-color: #7091A1; color: white; text-align: left; }.wkm-spannerlvl1left-lc {font-family: "Frutiger", "Verdana", "Helvetica", "Arial", sans-serif; font-weight: bolder; font-size: 12px; line-height: 120% ; border: none; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; background-color: #7091A1; color: white; text-align: left; }.wkm-spannerlvl2left {font-family: "Frutiger", "Verdana", "Helvetica", "Arial", sans-serif; font-weight: bolder; font-size: 12px; line-height: 120% ; border: none; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; background-color: #C0D1DA; color: black; text-align: left; }.wkm-spannerlvl3left {font-family: "Frutiger", "Verdana", "Helvetica", "Arial", sans-serif; font-weight: bolder; font-size: 10px; line-height: 120% ; border: none; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; background-color: #D3DFE5; color: black; text-align: left; }@media only screen and (max-width: 480px) { .wkm-SeeOnPhone { display: inline; } thead.wkm {font-family: "Frutiger", "Verdana", "Helvetica", "Arial", sans-serif !important; font-weight: bold !important; font-size: 11px !important; font-style: normal; background-color: #D3DFE5; margin-top: 0; margin-bottom: 0; vertical-align: bottom; } tbody.wkm {font-family: "Frutiger", "Verdana", "Helvetica", "Arial", sans-serif; font-size: 12px!important; font-weight: normal!important; font-style: normal!important; line-height: 120% !important; text-align: left!important; background-color: #F4F7F8!important; margin-top: 0!important; margin-bottom: 0!important; vertical-align: top!important; } tfoot.wkm {font-family: "Frutiger", "Verdana", "Helvetica", "Arial", sans-serif; font-size: 10px; font-weight: normal; font-style: normal; line-height: 120% ; text-align: left; background-color: #F4F7F8; margin-top: 0; margin-bottom: 0; vertical-align: top; } p.wkm-hang { margin-top: 0; margin-bottom: 0; margin-left: .5em; text-indent: -.5em; } th.wkm-intro {font-family: "Frutiger", "Verdana", "Helvetica", "Arial", sans-serif; font-weight: normal; font-size: 11px; font-style: normal; vertical-align: bottom; text-align: left; line-height: 120% ; background-color: white; border: none; border-collapse: collapse; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; margin-top: 0; margin-bottom: 0; } .wkm-spannerlvl1left {font-family: "Frutiger", "Verdana", "Helvetica", "Arial", sans-serif; font-weight: bolder; font-size: 11px; line-height: 120% ; text-transform: uppercase ; border: none; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; background-color: #7091A1; color: white; text-align: left; } .wkm-spannerlvl2left {font-family: "Frutiger", "Verdana", "Helvetica", "Arial", sans-serif; font-weight: bolder; font-size: 11px; line-height: 120% ; border: none; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; background-color: #C0D1DA; color: black; text-align: left; } .wkm-spannerlvl3left {font-family: "Frutiger", "Verdana", "Helvetica", "Arial", sans-serif; font-weight: bolder; font-size: 9px; line-height: 120% ; border: none; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; background-color: #D3DFE5; color: black; text-align: left; } }.wkm-straphead {font-family: "Frutiger", "Verdana", "Helvetica", "Arial", sans-serif; font-size: 14px; font-weight: bold; color: white; text-align: center; background-color: #557A8C; }table.wkm {border: none; border-collapse: collapse; }th.wkm-inside {font-family: "Frutiger", "Verdana", "Helvetica", "Arial", sans-serif !important; font-weight: bold !important; font-size: 11px !important; vertical-align: bottom; line-height: 120% ; text-align: left; border-top: none; border-bottom: none; border-left: 2px dotted gray; border-right: 2px dotted gray; border-collapse: collapse; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; }th.wkm {font-family: "Frutiger", "Verdana", "Helvetica", "Arial", sans-serif !important; font-weight: bold !important; font-size: 11px !important; vertical-align: bottom; line-height: 120% ; text-align: left; border-top: none; border-bottom: none; border-left: none; border-right: none; border-collapse: collapse; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; }td.wkm-last-topdashed-botNOrule { border-top: 2px dashed #b7b7b7; border-bottom: none; border-left: 2px dotted gray; border-right: none; border-collapse: collapse; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; }td.wkm-topdashed-botNOrule { border-top: 2px dashed #b7b7b7; border-bottom: none; border-left: 2px dotted gray; border-right: 2px dotted gray; border-collapse: collapse; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; }td.wkm-last-topdashed { border-top: 2px dashed #b7b7b7; border-bottom: none; border-left: 2px dotted gray; border-right: none; border-collapse: collapse; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; } td.wkm-first-topdashed { border-top: 2px dashed #b7b7b7; border-bottom: none; border-right: 2px dotted gray; border-left: none; border-collapse: collapse; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; }td.wkm-topdashed { border-top: 2px dashed #b7b7b7; border-bottom: none; border-left: 2px dotted gray; border-right: 2px dotted gray; border-collapse: collapse; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; }td.wkm-last-topdotted-botNOrule { border-top: 2px dotted #b7b7b7; border-bottom: none; border-left: 2px dotted gray; border-right: none; border-collapse: collapse; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; }td.wkm-first-topdotted-botNOrule { border-top: 2px dotted #b7b7b7; border-bottom: none; border-left: none; border-right: 2px dotted gray; border-collapse: collapse; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; }td.wkm-topdotted-botNOrule { border-top: 2px dotted #b7b7b7; border-bottom: none; border-left: 2px dotted gray; border-right: 2px dotted gray; border-collapse: collapse; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; }td.wkm-last-topdotted { border-top: 2px dotted #b7b7b7; border-bottom: none; border-left: 2px dotted gray; border-right: none; border-collapse: collapse; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; }td.wkm-first-topdotted { border-top: 2px dotted #b7b7b7; border-bottom: none; border-left: none; border-right: 2px dotted gray; border-collapse: collapse; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; }td.wkm-topdotted { border-top: 2px dotted #b7b7b7; border-bottom: none; border-left: 2px dotted gray; border-right: 2px dotted gray; border-collapse: collapse; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; }td.wkm-first-topNOrule { border-top: none; border-bottom: none; border-left: none; border-right: 2px dotted gray; border-collapse: collapse; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; }td.wkm-last-topNOrule { border-top: none; border-bottom: none; border-left: 2px dotted gray; border-right: none; border-collapse: collapse; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; }td.wkm-topNOrule { border-top: none; border-bottom: none; border-left: 2px dotted gray; border-right: 2px dotted gray; border-collapse: collapse; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; }td.wkm-last-botNOrule { border-top: none; border-bottom: none; border-left: 2px dotted gray; border-right: none; border-collapse: collapse; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; }td.wkm-first-botNOrule { border-top: none; border-bottom: none; border-left: none; border-right: 2px dotted gray; border-collapse: collapse; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; }td.wkm-botNOrule { border-top: none; border-bottom: none; border-left: 2px dotted gray; border-right: 2px dotted gray; border-collapse: collapse; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; }td.wkm-first-topbotNOrule { border-top: none; border-bottom: none; border-left: none; border-right: 2px dotted gray; border-collapse: collapse; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; }td.wkm-last-topbotNOrule { border-top: none; border-bottom: none; border-left: 2px dotted gray; border-right: none; border-collapse: collapse; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; }td.wkm-topbotNOrule { border-top: none; border-bottom: none; border-left: 2px dotted gray; border-right: 2px dotted gray; border-collapse: collapse; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; }td.wkm-first { border-top: none; border-bottom: none; border-left: none; border-right: 2px dotted gray; border-collapse: collapse; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; }td.wkm-last { border-top: none; border-bottom: none; border-left: 2px dotted gray; border-right: none; border-collapse: collapse; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; }td.wkm-foot-bot { border-top: none; border-bottom: 4px solid #C0D1DA; border-left: none; border-right: none; border-collapse: collapse; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; }td.wkm-foot { border-top: none; border-bottom: none; border-left: none; border-right: none; border-collapse: collapse; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; }td.wkm-list { border-top: none; border-bottom: none; border-left: none; border-right: none; border-collapse: collapse; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; }td.wkm { border-top: none; border-bottom: none; border-left: 2px dotted gray; border-right: 2px dotted gray; border-collapse: collapse; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; }p.wkm-sub-hang { margin-top: 0; margin-bottom: 0; margin-left: 3.1em; text-indent: -1em; padding-bottom: 0px; }p.wkm-foot-hang { font-family: "Frutiger", "Verdana", "Helvetica", "Arial", sans-serif!important; font-size: 11px !important; font-weight: normal !important; font-style: normal!important; line-height: 120%!important; text-align: left!important; margin-top: 0 !important; margin-bottom: 0 !important; margin-left: 1em!important; text-indent: -1em!important; padding-bottom: 0px!important; }p.wkm-foot { margin-top: 0!important; margin-bottom: 0!important; padding-bottom: 0px!important; font-family: "Frutiger", "Verdana", "Helvetica", "Arial", sans-serif!important; font-size: 11px !important; font-weight: normal !important; font-style: normal!important; line-height: 120%!important; text-align: left!important;}p.wkm-revision { font-size: 10px !important; text-align: right!important; margin-top: 0!important; margin-bottom: 0!important; padding-bottom: 0px!important; }p.wkm-bit-of-space { font-size: 10px!important; line-height: 100% !important; margin-top: 0!important; margin-bottom: 0!important; padding-bottom: 0px!important; }p.wkm {font-family: "Frutiger", "Verdana", "Helvetica", "Arial", sans-serif; font-size: 12px!important; font-weight: normal!important; font-style: normal!important; line-height: 120% !important; text-align: left!important; background-color: #F4F7F8!important; vertical-align: top!important; margin-top: 0!important; margin-bottom: 0!important; margin-right: 0!important; margin-left: 0!important; text-indent: 0!important; padding-bottom: 0px; }.wkm-brand { font-weight: bold; }.wkm-company { font-style: italic; font-weight: normal; }.wkm-spannernotehead {font-family: "Frutiger", "Verdana", "Helvetica", "Arial", sans-serif; font-weight: bold; font-size: 12px; line-height: 120% ; border: none; padding-top: 3px; padding-bottom: 3px; padding-right: 3px; padding-left: 3px; background-color: #7091A1; color: white; text-align: left; }

Blood Glucose Meter Compatibility with Test Strips

BLOOD GLUCOSE METER COMPATIBILITY WITH TEST STRIPS
Company Meters Test Strips
ABBOTT LABS
myfreestyle.com
FreeStyle Freedom Lite FreeStyle Lite
FreeStyle Lite FreeStyle Lite
FreeStyle Precision Neo
FreeStyle Precision Neo
ARKRAY
arkrayusa.com
Glucocard Expression Glucocard Expression Test Strips
Glucocard Shine Glucocard Shine Test Strips
Glucocard Shine Connex
Glucocard Shine Express
Glucocard Shine XL
Glucocard Vital Glucocard Vital Test Strips
ASCENSIA DIABETES CARE
ascensiadiabetes.com
Contour Next Contour Next Test Strips
Contour Next EZ
Contour Next Gen
Contour Next Link 2.4
Contour Next One
Contour Next USB
GE HEALTHCARE/BIONIME
bionimeusa.com
GE333 GE333
GE100 GE100
LIFESCAN
onetouch.com
OneTouch Ultra2 OneTouch Ultra
OneTouch Ultra Plus Flex OneTouch Ultra Plus
OneTouch Verio Flex OneTouch Verio
OneTouch Verio Reflect
NOVA DIABETES CARE
novacares.com
Nova Max Link Nova Max
Nova Max Plus Nova Max, Nova Max Ketone
PRODIGY DIABETES CARE
prodigymeter.com
Prodigy AutoCode Prodigy No Coding Test Strips
Prodigy Pocket
Prodigy Voice
ROCHE DIAGNOSTICS
accu‑chek.com
Accu-Chek Aviva* Accu-Chek Aviva Plus
Accu-Chek Guide Accu-Chek Guide
Accu-Chek Guide Link
Accu-Chek Guide Me
Accu-Chek Nano* Accu-Chek SmartView
TRIVIDIA HEALTH
trividiahealth.com
Sidekick Strips (supplied w. meter)
TRUE FOCUS TRUE FOCUS
TRUE METRIX TRUE METRIX
TRUE METRIX AIR
TRUE METRIX GO
NOTES

*Meter is no longer manufactured but test strips are still available for purchase

Not an inclusive list of products or medical devices. Please contact company for full product information.

(Rev. 1/2023)

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CAC Score Predicts MACE in Patients With Stable Chest Pain https://www.empr.com/home/news/cac-score-predicts-mace-in-patients-with-stable-chest-pain/ Fri, 15 Mar 2024 13:00:00 +0000 https://www.empr.com/?p=217085 Prevalence of obstructive coronary artery disease, revascularization rates increased with increasing CAC score.

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HealthDay News — For people with stable chest pain referred for invasive coronary angiography (ICA), the risk for major adverse cardiovascular events (MACE) is low among those with a low coronary artery calcium (CAC) score, according to a study published online March 5 in Radiology.

Federico Biavati, MD, from the Charité–Universitätsmedizin Berlin, and colleagues examined the prognostic value of CAC scoring for MACE in 1,749 study participants with stable chest pain initially referred for ICA. Participants were randomly assigned to ICA or coronary computed tomography (CT). CAC scores from noncontrast CT scans were classified as low, intermediate, and high (scores of 0, 1 to 399, and 400 or higher).

The researchers found an increase in the prevalence of obstructive coronary artery disease at CT angiography from 4.1 to 76.1% in the groups with CAC score 0 and CAC score 400 or higher. Across the same groups, there was an increase from 1.7 to 46.2% in revascularization rates. Lower MACE risk was seen in the groups with CAC scores 0 and 1 to 399 compared with the 400 or higher group (0.5 and 1.9%, respectively, vs 6.8%; hazard ratios, 0.08 and 0.27, respectively). There was no significant difference in MACE between the sexes.

“A coronary artery calcium score of 0 showed very low risk of major adverse cardiovascular events at follow-up, and increasing scores were associated with increasing rates of obstructive coronary artery disease, revascularization, and MACE,” the authors write.

Several authors disclosed ties to the pharmaceutical, medical device, and publishing industries.

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CDC Updates Recommendations for Hepatitis B Virus Screening https://www.empr.com/home/news/cdc-updates-recommendations-for-hepatitis-b-virus-screening/ Tue, 14 Mar 2023 13:05:00 +0000 https://www.empr.com/?p=192860

Risk-based testing recommendations expanded to include people who are or were incarcerated, those with history of sexually transmitted infections

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HealthDay News — Recommendations have been updated for screening and testing for hepatitis B virus (HBV) infection, according to research published in the March 10 issue of the US Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report.

Erin E. Conners, PhD, from the CDC in Atlanta, and colleagues updated and expanded the previously published recommendations for identification and management of chronic HBV infection with respect to screening for HBV infection in the US.

The authors note that recommendations include screening for hepatitis B using 3 laboratory tests at least once during a lifetime for adults. In addition, risk-based testing recommendations were expanded to include persons incarcerated or formerly incarcerated in a jail, prison, or other detention setting; persons with a history of sexually transmitted infections or multiple sex partners; and individuals with hepatitis C virus infection history. Anyone who requests HBV testing should receive it, regardless of risk disclosure, because people may be reluctant to disclose risks.

“Along with vaccination strategies, universal screening of adults and appropriate testing of persons at increased risk for HBV infection will improve health outcomes, reduce the prevalence of HBV infection in the United States, and advance viral hepatitis elimination goals,” the authors write.

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CHIRHOSTIM https://www.empr.com/drug/chirhostim/ Thu, 22 Jul 2021 11:57:47 +0000 https://www.empr.com/drug/chirhostim/ CLINITEST https://www.empr.com/drug/clinitest/ Thu, 22 Jul 2021 10:27:50 +0000 https://www.empr.com/drug/clinitest/ ColoTest Now Available Over-the-Counter for Detecting Fecal Occult Blood https://www.empr.com/home/news/colotest-now-available-over-the-counter-for-detecting-fecal-occult-blood/ Tue, 27 Feb 2024 19:48:04 +0000 https://www.empr.com/?p=216275 ColoTest is designed to detect blood in stool, which may be an early indication for colorectal cancer, diverticulitis, gastrointestinal disorders, colitis or polyps.]]>

ColoTest®, an over-the-counter (OTC) at-home immunochemical fecal occult blood test, has been available by Reese Pharmaceutical.

ColoTest is designed to detect blood in the stool, which may be an early indication of colorectal cancer, diverticulitis, gastrointestinal disorders, colitis or polyps. Each test includes a guide, an insert, a test cassette, a sample collection tube, and a collection paper. 

After collecting a stool sample, the test specimen is dispensed into the sample well of the test cassette. If the sample contains a concentration of human hemoglobin antibodies at or above 50ng/mL, the test line becomes visible indicating that the sample contains a detectable level of blood; the assay reading time is between 1 and 10 minutes. 

If blood is detected, the patient should follow-up with a colonoscopy. The sensitivity (true positive) and specificity (true negative) of fecal immunochemical tests for detecting cancer were reported to be 73.8% and 96.4%, respectively.

ColoTest is available in 1- and 2-count test kits. The retail price for a 1 test is $19.99.

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Conventional CRC Screening Accurate Only for Adults Aged 50 to 75 Years https://www.empr.com/reports/conventional-crc-screening-measure-does-not-reflect-status-in-adults-aged-younger-older-than-50-to-75-years-2/ Wed, 17 May 2023 18:36:52 +0000 https://www.gastroenterologyadvisor.com/?post_type=report&p=164196 The majority of colorectal cancer (CRC) diagnoses occur in military veterans who are aged 50 to 75 years and not up-to-date with screening. Additionally, 12.5% of cases occur in patients outside of the 50- to 75-year age range or in those with a high-risk personal or family history of CRC, according to study results presented at Digestive Disease Week (DDW), held from May 6 to 9, 2023 in Chicago, Illinois, and virtually.

Although more people have access to CRC screening through the Veterans Health Administration (VA) than the rest of the United States general population, CRC remains a leading cause of cancer in veterans. For the study, researchers examined predictors of CRC diagnosis and whether the conventional measure could provide an accurate CRC screening status among individuals aged younger or older than 50 to 75 years.

Researchers conducted a case-control study using data from the VA clinical database to examine the relationship between screening status and CRC diagnosis. Among the study participants (N=3,714), 55% where White, 23.9% did not report race or ethnicity, 15.8% were Black, 4.5% were Hispanic or Latino, and 0.8% were Asian. Patients also had diabetes (26.7%) and obesity (32.4%).

Individuals with CRC were matched to control individuals according to age, sex, and facility. Researchers also grouped patients into 5 categories regarding screening status:

  1. average-risk, aged 50 to 75 years, and up-to-date.
  2. average-risk, aged 50 to 75 years, and not up-to-date.
  3. average-risk, aged younger or older than 50 to 75 years, and up-to-date.
  4. average-risk, aged younger or older than 50 to 75 years, and not up-to-date.
  5. high-risk factors, such as inflammatory bowel disease, hereditary cancer syndromes, or family history of CRC.
The conventional measure of CRC screening, which focuses on average-risk individuals aged 50-75, does not reflect screening status in an important minority of patients with CRC.

The study used multivariable conditional logistic regression — adjusted for race and ethnicity, smoking history, obesity, diabetes, and alcohol consumption — to analyze the association between CRC and screening status. Patients in category 5 vs category 1 had an increased risk for CRC (odds ratio [OR], 5.58; 95% CI, 4.25-7.32). Asian vs White patients had a lower risk for CRC (OR, 0.55; 95% CI, 0.34-0.90), and Black patients had a higher risk (OR, 1.53; 95% CI 1.32-1.77). Diabetes (OR, 2.01; 95% CI, 1.78-2.26), obesity (OR, 1.18; 95% CI, 1.07-1.31), and heavy alcohol consumption (OR, 3.35; 95% CI, 2.85-3.94) were all associated with developing CRC.

Individuals with a history of smoking had a lower risk for CRC compared with never smokers (OR, 0.05; 95% CI, 0.04-0.06).

“The conventional measure of CRC screening, which focuses on average-risk individuals aged 50-75, does not reflect screening status in an important minority of patients with CRC,” the study authors wrote.

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Coronary Artery Disease Testing After Initial Heart Failure Hospitalization Aids Outcomes https://www.empr.com/home/news/coronary-artery-disease-testing-after-initial-heart-failure-hospitalization-aids-outcomes/ Mon, 29 Jan 2024 14:00:00 +0000 https://www.empr.com/?p=214658 Findings can persist with testing up to 90 days after discharge.

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HealthDay News — Coronary artery disease (CAD) testing within 90 days of hospitalization for heart failure is associated with a lower risk for heart failure readmission or all-cause mortality, according to a study published online January 18 in the Journal of General Internal Medicine.

Cheng‑Wei Huang, MD, from Kaiser Permanente Los Angeles Medical Center, and colleagues assessed whether widespread CAD testing in patients with new-onset heart failure leads to improved outcomes. The analysis included 2729 adults with new-onset heart failure with reduced ejection fraction hospitalized within 1 of 15 Kaiser Permanente Southern California medical centers between 2016 and 2021.

The researchers found that 54.5% of patients received CAD testing, and after a median of 1.8 years, the testing group had a reduced risk for heart failure readmission or all-cause mortality (adjusted hazard ratio, 0.71; 95% CI, 0.63 to 0.79). These results persisted across subgroups with a history of atrial fibrillation, diabetes, renal disease, myocardial infarction, or elevated troponin during hospitalization. Regardless of timing of CAD testing, findings were similar (early testing, or received testing before discharge, versus late testing, or up to 90 days after discharge: adjusted hazard ratio, 0.97; 95% CI, 0.81 to 1.16).

“Further studies are necessary to examine factors associated with testing as well as testing completion to identify areas that may be more suitable for intervention to improve testing rates,” the authors write.

Abstract/Full Text (subscription or payment may be required)

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CORTROSYN https://www.empr.com/drug/cortrosyn/ Thu, 22 Jul 2021 11:17:43 +0000 https://www.empr.com/drug/cortrosyn/ CRC Screening Uptake No Better With Use of FIT in At-Risk Individuals https://www.empr.com/home/news/crc-screening-uptake-no-better-with-use-of-fit-in-at-risk-individuals/ Wed, 25 Oct 2023 13:00:00 +0000 https://www.empr.com/?p=208937 FIT screening does not improve screening uptake and has lower rate of advanced colorectal neoplasia detection.

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HealthDay News — For first-degree relatives of patients with nonsyndromic colorectal cancer (CRC), fecal immunochemical testing (FIT) screening does not improve screening uptake compared with colonoscopy screening, according to a study published online October 24 in PLOS Medicine.

Natalia González-López, from the Hospital Universitario de Canarias in Tenerife, Spain, and colleagues examined whether uptake of FIT screening is superior to uptake of colonoscopy screening in a population of FDRs of patients with CRC. The open-label, parallel-group trial was conducted in 12 centers between February 2016 and December 2021. Eligible participants were FDRs of index cases younger than 60 years or having two or more index cases or a sibling with CRC, regardless of age at diagnosis; 1760 FDRs of 460 index cases were assessed for inclusion: 870 were assigned to undergo one-time colonoscopy or FIT (431 and 439, respectively).

The researchers found that of those assigned to undergo colonoscopy or FIT, 44.0% attended the appointment and signed informed consent: 34.1 and 35.9% underwent colonoscopy-based screening and FIT-based screening, respectively (odds ratio, 1.08; 95% CI, 0.82 to 1.44; P =.564). Compared with the FIT group, the colonoscopy group had a significantly higher detection rate of advanced colorectal neoplasia (odds ratio, 3.64; 95% CI, 1.55 to 8.53; P =.003). Throughout follow-up, there was no change noted in study outcomes.

“In the setting of an opportunistic screening, annual FIT does not increase the screening uptake compared to colonoscopy screening in FDR at high risk of developing CRC, resulting in a significantly lower detection rate of advanced colorectal neoplasia,” the authors write.

Several authors disclosed ties to Sysmex and other companies.

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Deductible for Breast Diagnostic Imaging May Discourage Follow-Up https://www.empr.com/home/news/deductible-for-breast-diagnostic-imaging-may-discourage-follow-up/ Thu, 06 Apr 2023 13:00:00 +0000 https://www.empr.com/?p=194763

Overall, 18.2% of patients agreed that they would skip screening mammography if they knew they had to pay a deductible for follow-up.

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HealthDay News — Having a deductible for diagnostic imaging generated from abnormal breast screening examination may discourage more than one-fifth of women from returning for recommended diagnostic imaging, according to a study published online April 4 in Radiology.

Michael Ngo, MD, from the Chobanian and Avedisian School of Medicine in Boston, and colleagues examined the percentage of people who would hypothetically skip diagnostic breast imaging if out-of-pocket (OOP) expenses existed. Data were included from 714 respondents to the statement, “If I knew I had to pay a deductible for additional imaging [to make sure my screening mammogram is normal], I would skip this additional imaging.”

The researchers found that 21.1, 59.4, and 19.5% of patients agreed they would skip imaging, disagreed, and were undecided, respectively, with responses varying by race or ethnicity, education level, annual household income, and insurance payer. Those identifying as Hispanic, with a high school education or less, with an annual household income of $35,000 or greater, and with Medicaid or no insurance made up the highest percentages of patients who would skip additional imaging (33.0, 31.0, 27.0, and 31.5%, respectively). Overall, 18.2% of patients agreed that they would skip screening mammography if they knew they had to pay a deductible for follow-up, while 65.8 and 16.0% disagreed and were undecided, respectively.

“Given that our study sample largely consisted of patients already at risk for delay in breast care, the high percentage of respondents who may delay indicated breast imaging due to OOP costs highlights the concern that these payments only exacerbate existing gaps in breast cancer outcomes,” the authors write.

One author disclosed financial ties to the medical device industry; a second author disclosed ties to the publishing and medical technology industries.

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EEG Model Predicts Response to SSRI Meds in Major Depressive Disorder https://www.empr.com/home/news/eeg-model-predicts-response-to-ssri-meds-in-major-depressive-disorder/ Fri, 29 Sep 2023 13:05:00 +0000 https://www.empr.com/?p=207571

Model achieved balanced accuracy of 64.2 percent in internal validation, 63.7 percent in external validation.

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HealthDay News — For patients with major depressive disorder, an electroencephalography (EEG)-based model can predict response to selective serotonin reuptake inhibitor (SSRI) medications, according to a study published online September 28 in JAMA Network Open.

Benjamin Schwartzmann, from Simon Fraser University in Surrey, British Columbia, Canada, and colleagues established a model based on EEG to predict response to two distinct SSRI medications in a prognostic study. EEG data were collected between 2011 and 2017 from 2 independent cohorts of participants with depression: the first Canadian Biomarker Integration Network in Depression (CAN-BIND) group and the Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care (EMBARC) consortium. Participants were aged 18 to 65 years and had a diagnosis of major depressive disorder; 125 participants from CAN-BIND received an eight-week treatment regimen of escitalopram treatment and 105 EMBARC participants were randomly assigned to eight weeks of sertraline or placebo.

The researchers found that the model achieved a balanced accuracy of 64.2%, with sensitivity and specificity of 66.1 and 62.3%, respectively, during internal validation with CAN-BIND. The model achieved balanced accuracy of 63.7% during external validation with EMBARC and achieved sensitivity and specificity of 58.8 and 68.5%, respectively. The balanced accuracy for the EMBARC placebo group was 48.7 percent, with sensitivity and specificity of 50.0 and 47.3 percent, respectively.

“These findings represent a substantial advancement toward using EEG in future clinical practice and supporting its potential to match patients with major depressive disorder to optimized treatment,” the authors write.

Several authors disclosed ties to the pharmaceutical industry.

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Eligibility for Lung Cancer Screening Up With 2021 USPSTF Recommendations https://www.empr.com/home/news/eligibility-for-lung-cancer-screening-up-with-2021-uspstf-recommendations/ Mon, 25 Mar 2024 13:00:00 +0000 https://www.empr.com/?p=217629 Of those newly eligible under 2021 criteria, 2,063,840 were aged 50 to 54 years and 4,020,879 had 20 to 29-pack-year smoking history.

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HealthDay News — Expanded US Preventive Services Task Force (USPSTF) criteria for lung cancer screening (LCS) in 2021 have resulted in a 65.9% increase in the number of eligible individuals, according to a research letter published online March 21 in JAMA Network Open.

Louise M. Henderson, PhD, from the University of North Carolina at Chapel Hill, and colleagues compared LCS prevalence in 2022 by sociodemographic characteristics and by state among individuals eligible according to 2013 and 2021 USPSTF recommendations.

The researchers found that in 2022, the weighted LCS-eligible population was 13,526,348 individuals per 2021 criteria and 8,154,440 individuals per 2013 criteria (65.9% increase). Using 2021 and 2013 criteria, the 2022 LCS prevalence was 16.4 and 19.6%, respectively; the number screened increased by 619,054. Of those newly eligible under 2021 criteria, 2,063,840 were aged 50 to 54 years and 4,020,879 had a 20- to 29-pack-year smoking history, with 6.1 and 13.1%, respectively, reporting LCS. Using the 2021 criteria, 2022 LCS prevalence estimates ranged from 8.6% in Wyoming to 28.7% in Rhode Island. Higher LCS prevalence rates were seen in Northeastern and Mid-Atlantic states.

“Our findings suggest that updated LCS eligibility criteria may be an important first step to reducing lung cancer disparities, although screening rates remained low,” the authors write. “Increasing LCS uptake nationwide should be a major public health priority.”

One author disclosed ties to Bristol Myers Squibb.

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FDA Approves Companion Diagnostic for Hemophilia B Gene Therapy Beqvez https://www.empr.com/home/news/fda-approves-companion-diagnostic-for-hemophilia-b-gene-therapy-beqvez/ Mon, 29 Apr 2024 20:25:00 +0000 https://www.empr.com/?p=219623 The Food and Drug Administration (FDA) has approved Labcorp’s nAbCyte™ Anti-AAVRh74var HB-FE Assay as a companion diagnostic to determine patient eligibility for treatment with Beqvez™ (fidanacogene elaparvovec-dzkt), a one-time gene therapy for hemophilia B.

Beqvez is indicated for the treatment of adults with moderate to severe hemophilia B who currently use factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes and, do not have neutralizing antibodies to adeno-associated virus serotype Rh74var (AAVRh74var) capsid as detected by an FDA-approved test.

The nAbCyte cell-based neutralizing antibody assay detects AAVRh74var pre-existing neutralizing antibodies, which could impact the efficacy of Beqvez. Patients should be tested for pre-existing antibodies prior to treatment. Test results are reported as being negative (not detected) or positive (detected). If a patient tests positive for antibodies to AAVRh74var, Beqvez should not be administered.

“The approval of the nAbCyte companion diagnostic represents a first for a gene therapy that treats eligible patients with hemophilia B, helping to bring clarity to physicians and patients who are considering Beqvez as a treatment option,” said Dr Sonal Bhatia, MD, Head of US Specialty Care Medical Affairs, Pfizer. “We believe this companion diagnostic is an important tool for evaluating patients who may be suitable for gene therapy as the treatment paradigm advances with the introduction of gene therapies like Beqvez.”

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FDA Clears Blood-Based Biomarker Tests for Risk Assessment of Preeclampsia https://www.empr.com/home/news/fda-clears-blood-based-biomarker-tests-for-risk-assessment-of-preeclampsia/ Fri, 19 May 2023 20:15:00 +0000 https://www.empr.com/?p=197158 The FDA clearance was based on data from the PRAECIS study.]]>

The Food and Drug Administration (FDA) has cleared the first blood-based biomarkers for risk assessment and clinical management of preeclampsia, a leading cause of maternal and fetal mortality and morbidity.

The Thermo Scientific B·R·A·H·M·S PlGF plus KRYPTOR and B·R·A·H·M·S sFlt-1 KRYPTOR biomarkers are designed to assess the risk of progressing to preeclampsia with severe features within the coming 2 weeks in pregnant women who have been hospitalized for hypertensive disorders of pregnancy. These assays run on the Thermo Scientific B·R·A·H·M·S KRYPTOR compact PLUS clinical chemistry analyzer; results can be delivered in less than 30 minutes.

The FDA clearance was based on data from the PRAECIS study (ClinicalTrials.gov Identifier: NCT03815110), which included more than 700 pregnant women hospitalized with hypertensive disorder presenting between 23 and 35 weeks of gestation. Results showed that women with a ratio serum soluble fms-like tyrosine kinase 1 (sFlt-1) to placental growth factor (PlGF) of at least 40 were at higher risk for adverse maternal outcomes compared with those with a ratio less than 40 (16.1% vs 2.8%; relative risk, 5.8; 95% CI, 2.8–12.2).

“FDA clearance and availability of these novel biomarker tests throughout the country will allow caregivers to better manage and potentially improve outcomes for both mothers and their newborns,” said Ravi Thadhani, MD, MPH, executive vice president of health affairs at Emory University and co-author of the PRAECIS study.

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FDA Clears Lab-Based Blood Test to Aid in Concussion Assessment https://www.empr.com/home/news/fda-clears-lab-based-blood-test-to-aid-in-concussion-assessment/ Wed, 08 Mar 2023 18:35:57 +0000 https://www.empr.com/?p=192679 Alinity i TBI lab test measures complementary biomarkers in blood plasma and serum that are tightly correlated to brain injury when elevated.]]>

The Food and Drug Administration (FDA) has cleared Abbott’s Alinity® i TBI lab test to aid in the evaluation of adults with suspected mild traumatic brain injury (mTBI; Glasgow Coma Scale score 13-15).

The Alinity i TBI test is a laboratory-based test that measures ubiquitin C-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein, 2 biomarkers in the blood correlated to brain injury when present in elevated concentrations. The test provides results with 96.7% sensitivity and 99.4% negative predictive value.

The new test can be used when a patient presents to the hospital with a suspected mTBI within 12 hours of injury. After a blood sample is drawn from the patient’s arm, the test is run on Abbott’s Alinity® i laboratory instrument, a high throughput instrument widely used in US hospitals and laboratories. Results are available in 18 minutes. Negative results rule out the need for a computed tomography (CT) scan.

The availability of a blood test provides clinicians with an objective method to quickly evaluate patients with mTBIs while eliminating the need for a head CT scan. According to the Company, the test could help reduce the number of unnecessary CT scans by up to 40%, potentially reducing health care costs and minimizing wait times in the emergency department.

“People sometimes minimize a hit to the head, thinking it’s no big deal. Others wonder if a visit to the doctor or emergency room for a possible concussion will provide them with meaningful answers or care,” said Beth McQuiston, MD, medical director in Abbott’s diagnostics business. “Now that this test will be widely available in labs across the country, medical centers will be able to offer an objective blood test than can aid in concussion assessment. That’s great news for both doctors and people who are trying to find out if they have suffered a traumatic brain injury.”

The Alinity i TBI blood test will run on the Alinity® i laboratory instrument, making TBI testing more widely available across the country. It is the first commercially available lab-based blood test for TBI and complements Abbott’s previously cleared i-STAT TBI Plasma test, the first rapid handheld blood test for TBI.

Reference

Abbott receives FDA clearance for first commercially available lab-based blood test to help evaluate concussion. News release. Abbott. Accessed March 7, 2023. https://prnmedia.prnewswire.com/news-releases/abbott-receives-fda-clearance-for-first-commercially-available-lab-based-blood-test-to-help-evaluate-concussion-301764488.html.

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