Add on SGLT2i or finerenone to RAAS inhibitor may provide kidney and CV protection in diabetics with CKD: Study

Add on SGLT2i or finerenone to RAAS inhibitor may provide kidney and CV protection in diabetics with CKD suggests BMC nephrology.

Given the substantial burden of chronic kidney disease associated with type 2 diabetes, an aggressive approach to treatment is required. Despite the benefits of guideline-directed therapy, there remains a high residual risk of continuing progression of chronic kidney disease and of cardiovascular events. Historically, a linear approach to pharmacologic management of chronic kidney disease has been used, in which drugs are added, then adjusted, optimized, or stopped in a stepwise manner based on their efficacy, toxicity, effects on a patient’s quality of life, and cost. However, there are disadvantages to this approach, which may result in missing a window of opportunity to slow chronic kidney disease progression. Instead, a pillar approach has been proposed to enable earlier treatment that simultaneously targets multiple pathways involved in disease progression.

Combination therapy in patients with chronic kidney disease associated with type 2 diabetes is being investigated in several clinical trials. In this article, we discuss current treatment options for patients with chronic kidney disease associated with type 2 diabetes and provide a rationale for tailored combinations of therapies with complementary mechanisms of action to optimize therapy using a pillar-based treatment strategy.

Reference:

Khan, M.S., Lea, J.P. Kidney and cardiovascular-protective benefits of combination drug therapies in chronic kidney disease associated with type 2 diabetes. BMC Nephrol 25, 248 (2024). https://doi.org/10.1186/s12882-024-03652-5

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New HFpEF-ABA Score Simplifies Screening for Undiagnosed HFpEF with Basic Patient Data: Study

USA: A recent advancement in cardiology promises to enhance the diagnosis and management of heart failure with preserved ejection fraction (HFpEF) with the HFpEF-ABA score. This innovative, evidence-based screening tool aims to streamline the identification of HFpEF, a condition that has historically posed challenges in accurate diagnosis and effective treatment.

This study, published in Nature Medicine, showed that the HFpEF-ABA score utilizes fundamental clinical data to enable swift and efficient screening for previously undiagnosed HFpEF in patients experiencing dyspnea.

The HFpEF-ABA score facilitates rapid and efficient screening for undiagnosed HFpEF risk in patients with dyspnea by utilizing just age, body mass index, and a history of atrial fibrillation, the researchers wrote.

Heart failure with preserved ejection fraction is frequently under-recognized in clinical settings. While the H2FPEF risk score can estimate the likelihood of HFpEF, it relies on imaging data that is not always accessible. Yogesh N. V. Reddy, The Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA, and colleagues sought to develop an HFpEF screening model based exclusively on clinical variables that can guide the need for echocardiography and further testing.

The following were the main findings of the study:

  • In a derivation cohort (n = 414, 249 women), a clinical model using age, body mass index, and history of atrial fibrillation (termed the HFpEF-ABA score) showed good discrimination (area under the curve (AUC) = 0.839).
  • The performance of the model was validated in an international, multicenter cohort (n = 736, 443 women; AUC = 0.813) and further validated in two additional cohorts: a cohort including patients with unexplained dyspnea (n = 228, 136 women; AUC = 0.840) and a cohort for which HF hospitalization was used instead of hemodynamics to establish an HFpEF diagnosis (n = 456, 272 women; AUC = 0.929).
  • Model-based probabilities were also associated with increased risk of HF hospitalization or death among patients from the Mayo Clinic (n = 790) and a US national cohort across the Veteran Affairs health system (n = 3076, 110 women).

The HFpEF-ABA score represents a significant step forward in managing heart failure with preserved ejection fraction. By offering a reliable and evidence-based method for screening, it promises to enhance diagnostic accuracy and ultimately improve patient outcomes in the fight against heart failure, the researchers concluded.

Reference:

Reddy, Y. N., Carter, R. E., Sundaram, V., Kaye, D. M., Handoko, M. L., Tedford, R. J., Andersen, M. J., Sharma, K., Obokata, M., Verbrugge, F. H., & Borlaug, B. A. (2024). An evidence-based screening tool for heart failure with preserved ejection fraction: The HFpEF-ABA score. Nature Medicine, 1-7. https://doi.org/10.1038/s41591-024-03140-1

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Liraglutide improves myocardial perfusion, myocardial energetics and exercise capacity in Diabetics without CVD: Study

Liraglutide improves myocardial perfusion, myocardial energetics and exercise capacity in Diabetics without CVD suggests a study published in the Journal of the American College of Cardiology.

Type 2 diabetes (T2D) is characterized by insulin resistance (IR) and dysregulated insulin secretion. Glucagon-like peptide-1 receptor agonist liraglutide promotes insulin secretion, whereas thiazolidinedione-pioglitazone decreases IR. This study aimed to compare the efficacies of increasing insulin secretion vs decreasing IR strategies for improving myocardial perfusion, energetics, and function in T2D via an open-label randomized crossover trial. Forty-one patients with T2D (age 63 years [95% CI: 59-68 years], 27 [66%] male, body mass index 27.8 kg/m2) [95% CI: 26.1-29.5 kg/m2)]) without cardiovascular disease were randomized to liraglutide or pioglitazone for a 16-week treatment followed by an 8-week washout and a further 16-week treatment with the second trial drug. Participants underwent rest and dobutamine stress 31phosphorus magnetic resonance spectroscopy and cardiovascular magnetic resonance for measuring the myocardial energetics index phosphocreatine to adenosine triphosphate ratio, myocardial perfusion (rest, dobutamine stress myocardial blood flow, and myocardial perfusion reserve), left ventricular (LV) volumes, systolic and diastolic function (mitral in-flow E/A ratio), before and after treatment. The 6-minute walk-test was used for functional assessments.

Results: Pioglitazone treatment resulted in significant increases in LV mass (96 g [95% CI: 68-105 g] to 105 g [95% CI: 74-115 g]; P = 0.003) and mitral-inflow E/A ratio (1.04 [95% CI: 0.62-1.21] to 1.34 [95% CI: 0.70-1.54]; P = 0.008), and a significant reduction in LV concentricity index (0.79 mg/mL [95% CI: 0.61-0.85 mg/mL] to 0.73 mg/mL [95% CI: 0.56-0.79 mg/mL]; P = 0.04). Liraglutide treatment increased stress myocardial blood flow (1.62 mL/g/min [95% CI: 1.19-1.75 mL/g/min] to 2.08 mL/g/min [95% CI: 1.57-2.24 mL/g/min]; P = 0.01) and myocardial perfusion reserve (2.40 [95% CI: 1.55-2.68] to 2.90 [95% CI: 1.83-3.18]; P = 0.01). Liraglutide treatment also significantly increased the rest (1.47 [95% CI: 1.17-1.58] to 1.94 [95% CI: 1.52-2.08]; P =0.00002) and stress phosphocreatine to adenosine triphosphate ratio (1.32 [95% CI: 1.05-1.42] to 1.58 [95% CI: 1.19-1.71]; P = 0.004) and 6-minute walk distance (488 m [95% CI: 458-518 m] to 521 m [95% CI: 481-561 m]; P = 0.009). Liraglutide treatment resulted in improved myocardial perfusion, energetics, and 6-minute walk distance in patients with T2D, whereas pioglitazone showed no effect on these parameters

Reference:

Amrit Chowdhary, Sharmaine Thirunavukarasu, Tobin Joseph, Nicholas Jex, Sindhoora Kotha, Marilena Giannoudi, Henry Procter, Lizette Cash, Sevval Akkaya, David Broadbent, Hui Xue, Peter Swoboda, Ladislav Valkovič, Peter Kellman, Sven Plein, Oliver J. Rider, Stefan Neubauer, John P. Greenwood, Eylem Levelt. Liraglutide Improves Myocardial Perfusion and Energetics and Exercise Tolerance in Patients With Type 2 Diabetes, Journal of the American College of Cardiology. Volume 84, Issue 6,  2024. Pages 540-557, ISSN 0735-1097, https://doi.org/10.1016/j.jacc.2024.04.064. (https://www.sciencedirect.com/science/article/pii/S0735109724074928)

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Probiotics combined with exercise significantly improve liver enzymes, lipid profile and insulin resistance in NAFLD patients: Study

Probiotics combined with exercise significantly improve liver enzymes, lipid profile and insulin resistance in NAFLD patients suggests a study published in the Nutrition & Metabolism.

Nonalcoholic fatty liver disease (NAFLD) is the most prevalent chronic liver ailment worldwide, in which nonpharmacological strategies have a considerable role in the treatment. Probiotic supplementation as well as physical exercise can improve cardiometabolic parameters, but further research is needed to determine the effects of combined treatment versus exercise alone in managing NAFLD-associated biomarkers, primarily liver enzymes, lipid markers, and insulin resistance. This systematic review and meta-analysis aimed to evaluate the effects of probiotic supplementation, combined with exercise versus exercise alone, on liver enzymes and cardiometabolic markers in patients with NAFLD. A systematic review and meta-analysis of randomized clinical trials was performed by searching PubMed, Scopus, and Web of Science databases up to April 2024. The search was restricted to articles published in the English language and human studies. Random effects models were used to calculate weighted mean differences (WMD). Results: Pooled estimates (9 studies, 615 patients, intervention durations ranging from 8 to 48 weeks) revealed that probiotics plus exercise decreased aspartate transaminase (AST) [WMD=-5.64 U/L, p = 0.02], gamma-glutamyl transferase (GGT) [WMD=-7.09 U/L, p = 0.004], low-density lipoprotein (LDL) [WMD=-8.98 mg/dL, p = 0.03], total cholesterol (TC) [WMD=-16.97 mg/dL, p = 0.01], and homeostatic model assessment for insulin resistance (HOMA-IR) [WMD=-0.94, p = 0.005] significantly more than exercise only.

However, probiotics plus exercise did not significantly change high-density lipoprotein (HDL) [WMD = 0.07 mg/dL, p = 0.9], fasting insulin [WMD=-1.47 µIU/mL, p = 0.4] or fasting blood glucose (FBG) [WMD=-1.57 mg/dL, p = 0.3] compared with exercise only. While not statistically significant, there were clinically relevant reductions in alanine aminotransferase (ALT) [WMD=-6.78 U/L, p = 0.1], triglycerides (TG) [WMD=-21.84 mg/dL, p = 0.1], and body weight (BW) [WMD=-1.45 kg, p = 0.5] for probiotics plus exercise compared with exercise only. The included studies exhibited significant heterogeneity for AST (I2 = 78.99%, p = 0.001), GGT (I2 = 73.87%, p = 0.004), LDL (I2 = 62.78%, p = 0.02), TC (I2 = 72.41%, p = 0.003), HOMA-IR (I2 = 93.86%, p = 0.001), HDL (I2 = 0.00%, p = 0.9), FBG (I2 = 66.30%, p = 0.01), ALT (I2 = 88.08%, p = 0.001), and TG (I2 = 85.46%, p = 0.001). There was no significant heterogeneity among the included studies for BW (I2 = 0.00%, p = 0.9). Probiotic supplementation combined with exercise training elicited better results compared to exercise alone on liver enzymes, lipid profile, and insulin resistance in patients with NAFLD.

Reference:

Kazeminasab, F., Miraghajani, M., Mokhtari, K. et al. The effects of probiotic supplementation and exercise training on liver enzymes and cardiometabolic markers in patients with non-alcoholic fatty liver disease: a systematic review and meta-analysis of randomized clinical trials. Nutr Metab (Lond) 21, 59 (2024). https://doi.org/10.1186/s12986-024-00826-8

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New MDHAQ Screening Tool Enhances Detection of Anxiety, Depression, and Fibromyalgia in RA and OA Patients: Study

US: To recognize
the comorbidities such as anxiety (ANX), depression (DEP), and fibromyalgia (FM)
associated with rheumatoid arthritis(RA) and osteoarthritis (OA) in routine care
practice, current research has discovered a new screening procedure called Multidimensional Health Assessment Questionnaire
(MDHAQ) to detect patient status, prognosis and response to treatments.

The study published in ACR Open Rheumatology proposes a high prevalence of ANX, DEP, and FM about 40% in patients
with OA and 36% in patients with RA. Furthermore, the
study found strong associations of
these comorbidities with poorer patient status, all assessed using a
single Multi-Dimensional Health Assessment Questionnaire (MDHAQ).

Additionally, researchers indicated that the MDHAQ can
be seamlessly integrated into routine clinical care for assessing comorbidities
associated with RA and OA.

OA and RA are often
linked to ANX, DEP, and FM, and despite the high prevalence of these
comorbidities, it is difficult to recognize by physicians in routine practice. To assess the comorbidities multiple questionnaires are required which
seems to be problematic.

To solve this issue MDHAQ
was designed which incorporated 4 indices within it, which are: RAPID3
to assess overall patient status, the Fibromyalgia Assessment Screening Tool
(FAST4), MDHAQ DEP screen (MDS2), and MDHAQ ANX screen (MAS2).

The advantage of this approach is that it involves a single questionnaire
that can be easily completed by patients in 5 to 10 minutes to screen for ANX, DEP, and FM.

To assess the reliability of MDHAQ,
Juan Schmukler,
Rush University Medical Center,
Chicago, Illinois and colleagues undertook a retrospective analysis of
MDHAQ data in unselected patients with OA or RA receiving routine care at one
setting included four indices within an MDHAQ: MDHAQ ANX screen, MDHAQ DEP
screen, Fibromyalgia Assessment Screening Tool, and RAPID3.

Unadjusted and age-adjusted
(Mantel-Haenszel) odds ratios (ORs) were used to evaluate
the prevalence of each comorbidity and associations with RAPID3 and its
components function, pain, and patient global scores.

Study findings reveal:

  • 40.4% of 361 patients with OA and 36.3% of 488
    patients with RA screened positive for ANX, DEP, and/or FM (8.1% and 7% for all
    three)
  • RAPID3 and each component were elevated in
    patients with positive screen results for ANX, DEP, and/or FM in both diagnoses
    (ORs of 2.6–35.8).

In conclusion, researchers approved the
reliability of using a single MDHAQ to
screen three common comorbidities linked with RA and OA.

Furthermore, they urged conducting studies
related to pain mechanisms according to ANX, DEP, and FM that would give
proper insights for understanding the pathophysiology and improving patient
management and outcomes.

Reference: Schmukler J, Malfait AM, Block JA, Pincus T. 36-40% of Routine Care
Patients With Osteoarthritis or Rheumatoid Arthritis Screen Positive for
Anxiety, Depression, and/or Fibromyalgia on a Single MDHAQ. ACR Open Rheumatol.
2024 Jul 16. doi: 10.1002/acr2.11711. Epub ahead of print. PMID: 39011669

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Poor Glycemic Control in diabetics Key to Mucormycosis Outcomes in COVID-19 patients; Masks and Oxygen Not to Blame, study finds

INDIA: The presence of diabetes mellitus with poor glycemic control was the reason for the mucormycosis
pandemic. COVID vaccination provided protection against severe COVID-19 as well
as against covid- associated mucormycosis, a recent study published in The
Journal of Associations of Physicians of India has concluded.

Contrary to popular belief, industrial oxygen and oxygen masks were not responsible for the mucormycosis pandemic, the researchers wrote. 

The study highlights the presence of uncontrolled
diabetes is the leading cause of mucormycosis and it leads to an increase in
the hospital stay of the patient. A long follow-up is required for patients
suffering from COVID with transient diabetes.

Transient diabetes is also known as transient
hyperglycemia. It refers to a temporary disruption in normal glucose
metabolism, often resulting in elevated blood sugar levels that revert to
normal once the underlying cause is resolved. Stress, increased cortisol
levels, and consumption of beta–blockers, corticosteroids, and diuretics are
the main leading causes of transient diabetes. Considering this, Prabhat
Agarwal, Professor of the Department of Medicine, S.N Medical College, Agra,
Uttar Pradesh, India, and colleagues aimed to determine that the Covid-19
infection spike in invasive fungal infection in the diabetic population.

For this purpose, the research team conducted a
prospective cohort study with patients suffering from mucormycosis. The study
was performed with the participation of 98 patients from referral hospitals in
India. The study was conducted from May 20, 2021, to November 30, 2022, and the
study protocol was approved by the Institutional Ethics Committee.

The patients were treated with an injection of
amphotericin-B with oral posaconazole therapy, every week periodically nasal
endoscopies were conducted which was coupled with radiological evaluations, and
progressive debridement was carried out as required. Amphotericin B (TRAMB)
injections with a dosage of 1 mL of 3.5Mg/mL solution for 5-7 days were
provided to the patients with orbital lesions. Oral hypoglycemic agents and
insulin were provided to the patients to maintain their strict control of blood
sugar levels.

They found the following results:

  • The
    mean age for patients was 55.5 years, with ages ranging from 28 to 88 years
  • Of
    the patients with mucormycosis, 63.3% were male and 37.8% were female. Among
    them, 55.7% of the males and 58.3% of the females were known to have diabetes.
  • A
    previous history of diabetes mellitus was found as an underlying comorbid
    condition in 56.7% of patients, while the remaining were diagnosed with
    new-onset diabetes mellitus.
  • At
    admission, sugar levels for known diabetics ranged from 112 to 494 mg/dL, and
    for newly diagnosed diabetics, they ranged from 132 to 356 mg/dL. Other
    comorbidities included hypertension (19.5%), ischemic heart disease (8.2%),
    chronic renal illness (3.09%), and one case (1.03%) of postoperative renal cell
    carcinoma that was disease-free.
  • The
    majority of cases (91.8%) were not vaccinated for COVID-19, while only two
    patients reported a history of vaccination with two doses, and six others had
    received only a single dose.
  • At
    the 1-year follow-up, 57.7% of patients were disease-free, 30.9% had died, and
    11.3% were lost to follow-up. There was a statistically significant difference
    in the mean glycated haemoglobin (HbA1c) levels at admission between known
    diabetics and newly diagnosed patients.
  • By
    the end of 1 year, a total of seven patients from the newly diagnosed diabetic
    group no longer required diabetes medication.

“Patients with mucormycosis should be monitored for extended periods, as some may experience transient diabetes, especially in the context of COVID. Additionally, further epidemiological research may be necessary to understand the high incidence of mucormycosis in the Indian subcontinent,” the researchers concluded. 

Reference

Agrawal, P., Singh, A. P., Chakotiya, P. S., Kumar,
V., Gautam, A., & Kumar, D. (2024). Long-term Outcome of Coronavirus
Disease-associated Mucormycosis: 1-year Follow-up Study from India. The
Journal of the Association of Physicians of India, 72(6),
44–48. https://doi.org/10.59556/japi.72.0564

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Statin Use Linked to Higher Glaucoma Risk in Hyperlipidemia Patients, suggests study

Researchers in a recent study have found that statin use is associated with a higher likelihood of developing glaucoma in adults with hyperlipidemia, even when “bad” cholesterol levels are optimal. This study was published in Ophthalmology Glaucoma journal by Tseng VL and colleagues. This population-based, cross-sectional study of 79,036 patients aged 40 and older in the All of Us Research Program database found that statin use was significantly associated with a higher prevalence of glaucoma.

Statins are majorly consumed for the management of cholesterol levels and for the prevention of heart disease. Prior studies concerning the association between statins and glaucoma were inconsistent. The new study, led by Victoria L. Tseng, MD, PhD, of the David Geffen School of Medicine at UCLA, finds more complex interactions, although some previous studies found a protective effect. The study was undertaken to elucidate the potential relationship between statin use and glaucoma in a diverse population with hyperlipidemia.

This analysis used the 2017 to 2022 data from the AoU Research Program, which included 79,742 participants with hyperlipidemia; 8% of them were taking statins. Their average age was 66.2 years, and 57.3% of them were women, while 64.1% were white. The adjusted odds ratios were used by the researchers comparing glaucoma prevalence of statin users versus statin non-users, stratifying by low-density lipoprotein cholesterol levels.

Results

  • The study found that statin use was associated with an increased prevalence of glaucoma compared to non-use (adjusted OR 1.13, 95% CI 1.01-1.26).

  • When stratifying by LDL-C levels, statin use was significantly associated with glaucoma in participants with optimal (aOR 1.39, 95% CI 1.05-1.82) and high LDL-C levels (aOR 1.37, 95% CI 1.09-1.70).

  • A positive association was noted between statin use and glaucoma prevalence in participants aged 60-69 years (aOR 1.28, 95% CI 1.05-1.56).

The results suggest that statin use may be linked to an increased risk for glaucoma; this finding was opposite to the previous views of a protective effect. A positive association was found in the relationship between statin use and glaucoma in different levels of LDL-C and age groups, suggesting that some other latent factors may come into play, which could affect this relation, such as the extent of hyperlipidemia and vascular health.

These findings underline the need for ophthalmologists to take into account cardiovascular status and related medications while estimating glaucoma risk. Information regarding general health factors of the patients, such as statin use, may facilitate an understanding of atypical glaucoma progression. Further studies need to be performed to elucidate the underlying mechanisms of this association and whether statins per se are associated with increased risk for glaucoma.

This association was positive: statin use increased the prevalence of glaucoma in adults with hyperlipidemia. This result underscores the holistic care of patients to address cardiovascular and ophthalmic factors to better manage and alleviate the risk of developing glaucoma in this population.

Reference:

Lee, S. Y., Paul, M. E., Coleman, A. L., Kitayama, K., Yu, F., Pan, D., & Tseng, V. L. (2024). Associations between statin use and glaucoma in the all of us research program. Ophthalmology. Glaucoma. https://doi.org/10.1016/j.ogla.2024.07.008

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Improving Quality of Life for Women with vulvar Lichen Sclerosus using Low Level Laser Therapy – Study

Lichen sclerosus (LS) is a long-lasting, inflammatory condition affecting the skin in the genital and nongenital areas. Recent study aimed to investigate whether low-level laser therapy (LLLT) can improve the quality of life in women with lichen sclerosus (LS) who have an insufficient response to topical treatments. The study was a descriptive prospective observational study conducted at the University Hospital of Southern Denmark between January 2016 and January 2018.

Study Design and Treatment Plan

The study included 100 women with LS who had an insufficient response to topical treatments such as ultrapotent steroids or calcineurin inhibitors. All participants received 10 LLLT treatments (808 nm, 500 mW) over an 8-week period, with the first 4 treatments planned twice per week and the remaining 6 treatments once per week. The effect of the treatment was monitored using a Danish health-related quality of life (HRQoL) tool called the DoloTest.

Results and Patient Demographics

A total of 94 patients completed the study, with a median age of 62 years. The results showed a statistically significant improvement in 7 of the 8 domains of the HRQoL test after the 10 LLLT treatments. The most significant improvements were observed in the domains of pain, low spirit, problems with more strenuous physical activity, and sleep. The only domain that did not show a statistically significant improvement was problems at work.

Subgroup Analysis

The study also analyzed the effect of LLLT in different patient subgroups. The results were statistically significant in all subgroups except for the smoking group. The effect seemed to be highest in patients under 62 years of age, those with a diagnostic delay of more than 2 years, those with a disease duration of more than 3 years, those with a weekly use of topical treatment above 4 times, and those who were diagnosed clinically.

Conclusion

The authors concluded that LLLT can be considered as a supplemental therapy to topical treatments in patients with LS who experience an insufficient response and poor quality of life. The study also found the visual effect of the HRQoL test to be useful for patients in understanding the impact of LS on their quality of life.

Key Points

Here are the 6 key points from the research paper:

1. The study investigated whether low-level laser therapy (LLLT) can improve the quality of life in women with lichen sclerosus (LS) who have an insufficient response to topical treatments.

2. The study included 100 women with LS who had an insufficient response to topical treatments. They received 10 LLLT treatments over an 8-week period, and the effect was monitored using a Danish health-related quality of life (HRQoL) tool called the DoloTest.

3. The results showed a statistically significant improvement in 7 of the 8 domains of the HRQoL test after the 10 LLLT treatments, with the most significant improvements observed in the domains of pain, low spirit, problems with more strenuous physical activity, and sleep.

4. The subgroup analysis found the effect of LLLT to be statistically significant in all subgroups except the smoking group. The effect seemed to be highest in patients under 62 years of age, those with a diagnostic delay of more than 2 years, those with a disease duration of more than 3 years, those with a weekly use of topical treatment above 4 times, and those who were diagnosed clinically.

5. The authors concluded that LLLT can be considered as a supplemental therapy to topical treatments in patients with LS who experience an insufficient response and poor quality of life.

6. The study found the visual effect of the HRQoL test to be useful for patients in understanding the impact of LS on their quality of life.

Reference –

Pia Kirstine Berthelsen, Sidsel Eb Ipsen & Mohammed R. Khalil (2024) Low-level laser therapy: an efficient supplement to treatments of vulvar Lichen sclerosus to improve quality of life, Journal of Obstetrics and Gynaecology, 44:1, 2349965, DOI: 10.1080/01443615.2024.2349965

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AI Tool Enhances Accuracy in Estimating Gestational Age from Blind Ultrasound Scans: Study

USA: A study published in JAMA Network found that a handheld ultrasonography device equipped with artificial intelligence, when used by novice operators, estimated gestational age as accurately as experienced sonographers utilizing conventional ultrasound machines.

Accurate gestational age (GA) assessment is crucial for quality pregnancy care, yet access to ultrasonography is often limited in low-resource settings.

Jeffrey S. A. Stringer, MD et. al. aimed to assess the accuracy of gestational age estimation using an AI-enabled ultrasonography tool operated by novice users without prior sonography training. The study developed a deep learning artificial intelligence (AI) model to estimate GA from blind ultrasonography sweeps, integrating it into the software of an affordable, battery-powered device.

The primary outcome measure was the mean absolute error (MAE) of both the index test and the study standard. It was determined by comparing each method’s gestational age estimate to the previously established GA, with equivalence defined as a difference within a prespecified margin of ±2 days.

This prospective diagnostic accuracy study enrolled 400 participants with viable, single, non-anomalous, first-trimester pregnancies in Lusaka, Zambia, and Chapel Hill, North Carolina. Credentialed sonographers established the “ground truth” gestational age (GA) using transvaginal crown-rump length measurement. At random follow-up visits throughout the pregnancy, including a primary evaluation window from 14 weeks 0 days to 27 weeks 6 days of gestation, novice users performed blind sweeps of the maternal abdomen using the AI-enabled device (index test). Meanwhile, credentialed sonographers conducted fetal biometry using high-specification machines (study standard).

The key points of the research are as follows:

In the primary evaluation window, the AI-enabled device achieved equivalence with the study standard, with a mean absolute error of 3.2 days compared to 3 days.

The percentage of assessments within 7 days of the established gestational age was similar between the two methods: 90.7% for the AI device and 92.5% for the study standard.

The device’s performance was consistent across prespecified subgroups, including participants from both the Zambia and North Carolina cohorts, as well as those with a high body mass index.

The researchers concluded that between 14 and 27 weeks gestation, novice users without prior ultrasonography training could estimate gestational age as accurately with a low-cost, point-of-care AI tool as credentialed sonographers using high-specification machines for standard biometry. The research findings have significant implications for enhancing obstetric care in low-resource environments, aligning with the World Health Organization’s objective to provide gestational age estimation for all pregnant individuals.

Reference

Stringer JSA, et al “Diagnostic accuracy of an integrated AI tool to estimate gestational age from blind ultrasound sweeps” JAMA 2024; DOI: 10.1001/jama.2024.10770.

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Aspirin Use Shows Greater Benefit for Colon Cancer Risk Reduction in Individuals with Unhealthy Lifestyles: JAMA

USA: A recent study published in JAMA Oncology concluded that people who are at higher risk for colorectal cancer due to an unhealthy lifestyle may benefit from aspirin in terms of reducing their risk factors.

Colorectal cancer is the cancer of the colon or rectum. Unhealthy lifestyle, obesity, low physical activity, smoking, heavy alcohol consumption, presence of ulcerative colitis, and Crohn’s disease are the risk factors which are associated with colorectal cancer. Considering this, Daniel R. Sikavi, from the Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston, et.al conducted a study to evaluate whether the usage of aspirin is linked to the risk of colorectal cancer considering different lifestyle risk factors.

For this purpose, the research team conducted a prospective cohort study involving women nurses from 1980 to 2018 and male health professionals from 1986 to 2018. Data analysis was conducted between October 1, 2021- May 22, 2023.

The study assessed several outcomes, including the 10-year cumulative incidence of colorectal cancer (CRC) adjusted for multiple variables, the absolute risk reduction (ARR) with regular aspirin use, and the number needed to treat to achieve this benefit, all based on lifestyle scores. Additionally, it evaluated the multivariable-adjusted hazard ratios for developing CRC according to different lifestyle scores. Based on body mass index, alcohol intake, physical activity, and smoking a healthy lifestyle score was calculated. Regular consumption of aspirin tablets was defined as taking 2 or more standard tablets each week.

The findings revealed that:

• The average baseline age of the 107,655 study participants—comprising 63,957 women from the Nurses’ Health Study and 43,698 men from the Health Professionals Follow-Up Study—was 49.4 years.

• Over 3,038,215 person-years of follow-up, 2,544 new cases of colorectal cancer were recorded. The 10-year cumulative incidence of CRC was 1.98% for participants who used aspirin regularly, compared to 2.95% for those who did not, resulting in an absolute risk reduction (ARR) of 0.97%.

• The ARR from aspirin use was highest among individuals with the poorest lifestyle scores and decreased progressively with improving lifestyle scores.

• The 10-year absolute risk reduction for participants with lifestyle scores of 0 to 1 (indicating the least healthy lifestyles) was 1.28%. In comparison, the ARR for those with lifestyle scores of 4 to 5 (indicating the healthiest lifestyles) was 0.11%.

• The number needed to treat with aspirin over 10 years was 78 for participants with scores of 0 to 1, 164 for those with a score of 2, 154 for those with a score of 3, and 909 for those with scores of 4 to 5.

• Among the elements of the healthy lifestyle score, the most significant differences in absolute risk reduction (ARR) from aspirin use were found for body mass index and smoking.

“The researchers concluded that lifestyle risk factors are valuable for identifying individuals who have a more favorable risk-benefit profile for cancer prevention with aspirin use”, the researchers concluded.

Reference

Sikavi, D. R., Wang, K., Ma, W., Drew, D. A., Ogino, S., Giovannucci, E. L., Cao, Y., Song, M., Nguyen, L. H., & Chan, A. T. (2024). Aspirin Use and Incidence of Colorectal Cancer According to Lifestyle Risk. JAMA oncology, 10.1001/jamaoncol.2024.2503. Advance online publication. https://doi.org/10.1001/jamaoncol.2024.2503

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