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

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)

HealthDay News — Artificial intelligence (AI)-based computer-aided detection (CAD) software improves the detection of actionable lung nodules on chest radiographs, without increased false-referral rates, according to a study published online February 7 in Radiology.

Ju Gang Nam, MD, PhD, from the Artificial Intelligence Collaborative Network at the Seoul National University Hospital and College of Medicine in South Korea, and colleagues examined whether commercial AI-based CAD software can improve the detection rate of actionable lung nodules on chest radiographs in a single-center study. Participants who underwent chest radiography between July 2020 and December 2021 were enrolled and randomly assigned into an AI group and non-AI (control) group (5238 to each group). Each radiograph was interpreted by one of three radiologists with 13 to 36 years of experience.

The researchers found that the trial met the predefined primary outcome, with an improved detection rate of actionable nodules in the AI vs non-AI group (0.59 vs 0.25%; odds ratio, 2.4). For malignant lung nodules, the detection rate was higher in the AI than non-AI group (0.15 vs 0.0%). Similar false-referral rates were seen for the AI and non-AI groups (45.9 vs 56.0%); positive-report rates were also similar between the groups (2.3 vs 1.9%).

“The improved detection rate of actionable lung nodules with a similar false-referral rate suggests that using AI-based CAD may improve lung cancer diagnosis without imposing an additional radiation hazard,” the authors write.

Several authors disclosed financial ties to the medical device industry.

Abstract/Full Text

Editorial

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)

HealthDay News — Americans will continue to be able to get free preventive health care services, at least for now.

The US Court of Appeals for the Fifth Circuit in New Orleans temporarily blocked a lower court decision on Monday, pausing a ruling that challenged an Affordable Care Act (ACA) provision that all health plans cover certain care, The New York Times reported.

The earlier ruling in March, by Judge Reed O’Connor of the Federal District Court for the Northern District of Texas, would have immediately eliminated access to a long list of free preventive services mandated under the ACA since 2010. This was one of the most popular provisions of the ACA and includes depression screening for teens and drugs that prevent HIV transmission for about 150 million Americans enrolled in private employer-sponsored health insurance or through the ACA marketplaces, The Times noted.

O’Connor maintained that the US Preventive Services Task Force, which recommends the list of services, was not appointed by Congress. He ruled that the group did not have the constitutional authority to make a decision about health care services. The USPSTF is an independent group of experts that makes evidence-based recommendations on effective ways to prevent disease and prolong life.

This is not O’Connor’s only ruling on ACA provisions. He ruled in 2018 that the ACA was unconstitutional, a ruling that was later overturned by the US Supreme Court. O’Connor also ruled last September that the ACA mandate requiring coverage of an HIV prevention pill violated a company’s religious freedom, according to the news report.

Americans will keep this free preventive health care while the case works its way through the appeals process. It could end up in the Supreme Court.

The New York Times Article

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)

HealthDay News — Recommendations have been issued by the American Society of Regional Anesthesia (ASRA) and Pain Medicine for interventional pain procedures during the current contrast shortage.

Lynn Kohan, MD, from ASRA, and colleagues developed recommendations for interventional pain procedures during the current contrast shortage, resulting from the shutdown of a production facility in Shanghai.

The authors note that risk stratification should be used to determine which procedures can be delayed until contrast supply resumes. Alternative forms of visualization, such as ultrasound, should be considered when feasible. In non-neuraxial injections, the use of gadolinium can be considered. Gadolinium-based contrast agents should not be used in spine-related procedures in the absence or shortage of iodinated contrast medium. Lumbar interlaminar epidural injections, sacroiliac and facet joint injections, lumbar medial branch blocks, and radiofrequency denervation can be performed without use of contrast.

Whenever possible, multidose vials should be used for single patients. If a multidose vial is to be used for more than one patient, the US Pharmacopeia 797 standard of practice as well as US Centers for Disease Control and Prevention guidelines must be followed. Following the guidance of the state board of pharmacy or other regulatory body also is recommended.

More Information

The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for Lucira COVID-19 & Flu Home Test, the first over-the-counter (OTC) at-home diagnostic test that can detect and differentiate between SARS-CoV-2 and influenza viruses in individuals 2 years of age and older.

The Lucira COVID-19 & Flu Home test is a single-use, nucleic acid amplification test intended for individuals with signs and symptoms consistent with a respiratory tract infection, including COVID-19. The at-home test works by swabbing the nasal cavity and swirling the sample in a vial, which is then placed in a test unit. Results are displayed in the test unit within 30 minutes and determine whether an individual is positive or negative for: Influenza A, Influenza B, and COVID-19. Individuals should report all results to their health care provider.

In symptomatic individuals, the Lucira COVID-19 & Flu Home Test was found to correctly identify 99.3% of negative and 90.1% of positive Influenza A samples, 100% of negative and 88.3% of positive COVID-19 samples, and 99.9% of negative Influenza B samples. The FDA is requiring Lucira to continue collecting samples to determine the test’s ability to detect Influenza B in real world settings as there were not enough cases of Influenza B circulating to include in the study; the test was able to identify the virus in contrived specimens.

“Today’s authorization of the first OTC test that can detect Influenza A and B, along with SARS-CoV-2, is a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “The FDA strongly supports innovation in test development, and we are eager to continue advancing greater access to at-home infectious disease testing to best support public health needs.”

It is unclear when the test will be available as Lucira is working to secure a financial partner to resume manufacturing.

References

1. FDA authorizes first over-the-counter at-home test to detect both influenza and COVID-19 viruses. US Food and Drug Administration. February 24, 2023. Accessed February 27, 2023. https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-over-counter-home-test-detect-both-influenza-and-covid-19-viruses.
2. Lucira Health announces FDA authorization of first & only at-home combination COVID-19 & flu test and comments on Chapter 11 Bankruptcy filing. News release. Lucira Health. Accessed February 27, 2023. https://www.globenewswire.com/news-release/2023/02/27/2616067/0/en/Lucira-Health-Announces-FDA-Authorization-of-First-Only-At-Home-Combination-Covid-19-Flu-Test-and-Comments-on-Chapter-11-Bankruptcy-Filing.html.

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.

Abstract/Full Text

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.

Abstract/Full Text

Blood Glucose Meter Compatibility with Test Strips

The Food and Drug Administration (FDA) has approved Bludigo (indigotindisulfonate sodium, USP) as a diagnostic dye indicated for use as a visualization aid in the cystoscopic assessment of the integrity of the ureters in adults following urological and gynecological open, robotic, or endoscopic surgical procedures.

Indigotindisulfonate is a dye excreted by the kidney through tubular secretion that enhances visualization of the ureteral orifices by its deep blue color. The approval was based on data from a randomized, intrapatient controlled, blind to dose, multicenter phase 3 study (ClinicalTrials.gov Identifier: NCT04228445), which evaluated the efficacy and safety of Bludigo in 118 adults undergoing endoscopic urological or gynecological surgical procedures including cystoscopic (58%), robotic (28%), and transvaginal (14%) approaches.

Patients were randomly assigned (1:1) to receive Bludigo 2.5mL or 5mL intravenously prior to the end of the surgical procedure. Each patient underwent cystoscopy and received 5mL of sodium chloride injection 0.9% followed by the randomized Bludigo dose for visualization of urinary flow from the ureteral orifices.

The conspicuity of the urine flow from the ureteral orifices was assessed in a blinded fashion by 2 independent central reviewers using a 5-point scale. Surgeons also reviewed and scored conspicuity of the urine flow. The responder for a ureter was defined as the difference in conspicuity score between Bludigo and sodium chloride being at least 1 point difference and the conspicuity score after Bludigo alone being greater than or equal to 3.

Results demonstrated that the following proportion of patients who received Bludigo 5mL were responders for the left and right ureter, respectively:

• Reviewer 1: 63% (95% CI, 48-77); 76% (95% CI, 61-87).
• Reviewer 2: 78% (95% CI, 63-88); 82% (95% CI, 68-91).
• Surgeon: 71% (95% CI, 57-83); 82% (95% CI, 68-91).

Bludigo is not recommended for use in patients with an estimated glomerular filtration rate less than 30mL/min. The most common adverse reactions reported with Bludigo were constipation, nausea, vomiting, abdominal pain, pyrexia, ALT increase, and dysuria.

Bludigo is supplied in a single-dose ampule containing 40mg/5mL (8mg/mL) of indigotindisulfonate sodium. According to Provepharm, the product is expected to be available in the US soon.

References

1. Provepharm announces that it has received FDA approval for Bludigo^TM (indigotindisulfonate sodium, USP) Injection. News release. Provepharm Inc. Accessed July 12, 2022. https://www.prnewswire.com/news-releases/provepharm-announces-that-it-has-received-fda-approval-for-bludigotm-indigotindisulfonate-sodium-usp-injection-301584954.html
2. Bludigo. Package insert. Provepharm Inc.; 2022. Accessed July 12, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216264s000lbl.pdf

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.

Abstract/Full Text

Editorial (subscription or payment may be required)

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.

Abstract/Full Text

Detect, Inc. is voluntarily recalling 3 lots of the Detect COVID-19 Test due to an increased risk of false negative results.

The Detect COVID-19 Test is a molecular, over-the-counter test used to identify SARS-CoV-2 in self-collected nasal swabs. The affected lots (HB264, HY263, and HY264) were distributed to customers from July 26, 2022 to August 26, 2022; all have a use by date of January 1, 2023.

To date, the Company has not received any reports of false negative results related to the affected lots; the recall was issued out of an abundance of caution. According to the Company, the reliability of positive test results is not affected.

Customers can obtain a refund for a recalled test by contacting Detect customer support at (855) 322-3692 or via email at support@detect.com.

Reference

Voluntary recall of three detect COVID-19 test lots. News release. Detect. Accessed December 13, 2022. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/voluntary-recall-three-detect-covid-19-test-lots.