incidence

Major modifiable risk factors for childhood food allergies include delayed introduction of solid foods and early treatment with antibiotics. James W. Mold, MD, MPH

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Importance: The incidence and risk (predictive) factors for early life food allergy development remain uncertain.

Objective: To estimate the incidence and quantify risk factors for food allergy development.

Data sources: MEDLINE and Embase were systematically searched to January 1, 2025. Data were analyzed from June 1, 2025, to November 25, 2025.

Study selection: Incidence estimates included studies confirming food allergy via food challenge. Risk factor analyses included cohort, case-control, and cross-sectional studies in any language assessing children younger than 6 years using multivariable analyses.

Data extraction and synthesis: Paired reviewers independently extracted data. Random-effects meta-analyses pooled incidence and adjusted odds ratios (ORs). Risk of bias was assessed using the QUIPS tool, and certainty of evidence assessed using GRADE.

Main outcome and measure: The primary outcome was food allergy to age 6 years.

Results: A total of 190 studies involving 2.8 million participants across 40 countries were analyzed. Among studies using food challenge, overall food allergy incidence was likely 4.7% (moderate certainty). Among 176 studies identifying 342 risk factors with varying certainty, the strongest and most certain factors included prior allergic conditions (eg, atopic dermatitis [eczema] within the first year of life [OR, 3.88; risk difference [RD], 12.0%; 95% CI, 8.8%-15.7%], allergic rhinitis [OR, 3.39; RD, 10.1%; 95% CI, 6.7%-14.4%], and wheeze [OR, 2.11; RD, 5.0%; 95% CI, 2.1%-8.8%]), severity of atopic dermatitis (OR, 1.22; RD, 1.0%; 95% CI, 0.6%-1.6%), increased skin transepidermal water loss (OR, 3.36; RD, 10.0%; 95% CI, 6.3%-14.8%), filaggrin gene sequence variations (OR, 1.93; RD, 4.2%; 95% CI, 2.4%-6.4%), delayed solid food introduction (eg, peanut after age 12 months [OR, 2.55; RD, 6.8%; 95% CI, 1.9%-14.6%]), infant antibiotic use (first month [OR, 4.11; RD, 12.8%; 95% CI, 0.4%-40%], first year [OR, 1.39; RD, 1.8%; 95% CI, 0.8%-3.1%], during pregnancy [OR, 1.32; RD, 1.5%; 95% CI, 0.6%-2.5%]), male sex (OR, 1.24; RD, 1.1%; 95% CI, 0.7%-1.6%), firstborn child (OR, 1.13; RD, 0.6%; 95% CI, 0.3%-1.0%), family history of food allergy (eg, mother [OR, 1.98; RD, 4.4%; 95% CI, 2.5%-6.8%], father [OR, 1.69; RD, 3.2%; 95% CI, 1.3%-5.5%], both parents [OR, 2.07; RD, 4.8%; 95% CI, 1.3%-5.5%], siblings [OR, 2.36; RD, 6.0%; 95% CI, 4.4%-8.0%]), parental migration (OR, 3.28; RD, 9.7%; 95% CI, 4.9%-16.3%), self-identification as Black (vs White [OR, 3.93; RD, 12.1%; 95% CI, 5.2%-22.5%], vs non-Hispanic White [OR, 2.23; RD, 5.5%; 95% CI, 3.0%-8.7%]), and cesarean delivery (OR, 1.16; RD, 1.0%; 95% CI, 0.3%-1.2%). Factors like low birth weight, postterm birth, maternal diet, and stress during pregnancy showed no significant risk difference.

Conclusions and relevance: In this meta-analysis, the most credible risk factors associated with development of childhood food allergy are a combination of major and minor risk factors, including early allergic conditions (atopic march/diathesis), delayed allergen introduction, genetics, antibiotic exposure, demographic factors, and birth-related variables.

Author/s:

Nazmul Islam, Alexandro W L Chu, Falana Sheriff, Farid Foroutan, Gordon H Guyatt, Romina Brignardello-Petersen, Paul Oykhman, Alfonso Iorio, Ariel Izcovich, Katherine M Morrison, Yetiani Roldan Benitez

Lung Cancer in Nonsmoking Individuals: A Review

Megan George — Tue, 02 Dec 2025 15:53:35 +0000

Date Added:

December 2, 2025

Journal/Publication:

JAMA

Publication Date:

October 20, 2025

URL:

Lung Cancer in Nonsmoking Individuals: A Review

Type:

Meta-analyses, Reviews, and Guidelines

DOI (1):

10.1001/jama.2025.17695

Keywords

Early Detection of Cancer

PMID (1):

41114991

MeSH

Adenocarcinoma* / diagnosis

Adenocarcinoma* / epidemiology

Adenocarcinoma* / genetics

Adenocarcinoma* / therapy

Anaplastic Lymphoma Kinase / genetics

Carcinoma

Adenosquamous* / diagnosis

Adenosquamous* / epidemiology

Adenosquamous* / genetics

Adenosquamous* / therapy

Squamous Cell* / diagnosis

Squamous Cell* / epidemiology

Squamous Cell* / genetics

Squamous Cell* / therapy

Chemoradiotherapy

Adjuvant / methods

Early Detection of Cancer / standards

ErbB Receptors / genetics

Lung Neoplasms* / diagnosis

Lung Neoplasms* / epidemiology

Lung Neoplasms* / genetics

Lung Neoplasms* / therapy

male

Mass Screening / standards

Mutation

Neoplasm Staging

Non-Smokers* / statistics & numerical data

Pneumonectomy

practice guidelines as topic

Receptor Protein-Tyrosine Kinases / antagonists & inhibitors

Receptor Protein-Tyrosine Kinases / genetics

risk factors

Sex Factors

Small Cell Lung Carcinoma* / diagnosis

Small Cell Lung Carcinoma* / epidemiology

Small Cell Lung Carcinoma* / genetics

Small Cell Lung Carcinoma* / therapy

Smoking / adverse effects

tomography

X-Ray Computed / standards

Tyrosine Kinase Inhibitors / therapeutic use

A review of current knowledge regarding lung cancer in non-smokers. James W. Mold, MD, MPH

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Importance: Lung cancer in nonsmoking individuals (defined as people who have smoked fewer than 100 cigarettes in their lifetime) accounts for 15% to 20% of all lung cancer cases worldwide. In the US, the annual incidence of lung cancer in nonsmoking individuals is 14.4 to 20.8 per 100 000 person-years in females and 4.8 to 12.7 per 100 000 person-years in males.

Observations: Most lung cancers in nonsmoking individuals are histologically adenocarcinomas (60%-80%) with the remainder being squamous or adenosquamous (10%-20%) and rarely small cell lung cancer (<10%). Risk factors include exposure to passive smoking, radon exposure, air pollution, asbestos, and history of lung cancer in a first-degree family member. Therapeutically targetable genomic variants, such as EGFR mutations or ALK gene rearrangements, are more common in tumors from nonsmoking individuals compared with those with a smoking history (defined as people who currently or formerly smoked) (43% vs 11% for EGFR and 12% vs 2% for ALK). In contrast, tumor mutation burden, the number of somatic mutations in a tumor cell, is lower in lung cancer among nonsmoking individuals (0-3 mutations/megabase [Mb] vs 0-30 mutations/Mb). Similar to individuals with a history of smoking, nonsmoking individuals with lung cancer may present with wheeze, chest pain, dyspnea, hemoptysis, or symptoms attributable to metastatic disease (eg, bone pain and headache) or be diagnosed with incidentally detected disease. The US Preventive Services Task Force does not currently recommend lung cancer screening with low-dose computed tomographic scans for nonsmoking individuals, although screening guidelines vary globally. Treatment typically involves a combination of surgery, radiotherapy, and systemic therapies depending on stage, performance status, and molecular features of the tumor. Comprehensive next-generation sequencing should be performed on stage Ib to IIIa lung cancer tumor tissue from nonsmoking individuals because actionable genomic alterations, such as EGFR mutations or ALK gene rearrangements, are treated with targeted therapy such as the tyrosine kinase inhibitors osimertinib or lorlatinib, respectively. Median survival among nonsmoking individuals with advanced non-small cell lung cancer (stage IIIb or higher) and actionable genomic alterations can exceed 3 to 5 years, while survival without these genomic alterations is similar to lung cancer in people with a history of smoking (1-2 years).

Conclusions: Lung cancer in nonsmoking individuals accounts for 15% to 20% of lung cancer cases worldwide. Among patients with lung cancer, nonsmoking individuals are more likely to have genomic alterations such as EGFR mutations or ALK gene rearrangements, and these patients have improved survival when treated with tyrosine kinase inhibitors compared with chemotherapy.

Author/s:

Cian Murphy, Tej Pandya, Charles Swanton

Long-Term Anticoagulation Discontinuation After Catheter Ablation for Atrial Fibrillation: The ALONE-AF Randomized Clinical Trial

Megan George — Tue, 02 Sep 2025 13:46:16 +0000

Date Added:

September 2, 2025

Journal/Publication:

JAMA

Publication Date:

August 31, 2025

URL:

Long-Term Anticoagulation Discontinuation After Catheter Ablation for Atrial Fibrillation: The ALONE-AF Randomized Clinical Trial

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1001/jama.2025.14679

Keywords

clinical pharmacy and pharmacology

PMID (1):

40886309

MeSH

ischemic attack, transient

Discontinuation of anticoagulants after catheter ablation for atrial fibrillation appears to be am appropriate option. James W. Mold, MD, MPH

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Importance: Data from randomized clinical trials on a long-term anticoagulation strategy for patients after catheter-based ablation for atrial fibrillation (AF) are lacking.

Objective: To evaluate whether discontinuing oral anticoagulant therapy provides superior clinical outcomes compared with continuing oral anticoagulant therapy in patients without documented atrial arrhythmia recurrence after catheter ablation for AF.

Design, setting, and participants: A randomized clinical trial including 840 adult patients (aged 19-80 years) who were enrolled and randomized from July 28, 2020, to March 9, 2023, at 18 hospitals in South Korea. Enrolled patients had at least 1 non-sex-related stroke risk factor (determined using the CHA2DS2-VASc score [range, 0-9]) and no documented recurrence of atrial arrhythmia for at least 1 year after catheter ablation for AF. The CHA2DS2-VASc score is used as an assessment of stroke risk among patients with AF (calculated using point values for congestive heart failure, hypertension, ≥75 years of age, diabetes, stroke or transient ischemic attack, vascular disease, between 65 and 74 years of age, and sex category). The date of final follow-up was June 4, 2025.

Interventions: The patients were randomly assigned in a 1:1 ratio to discontinue oral anticoagulant therapy (n = 417) or continue oral anticoagulant therapy (with direct oral anticoagulants; n = 423).

Main outcomes and measures: The primary outcome was the first occurrence of a composite of stroke, systemic embolism, and major bleeding at 2 years. Individual components of the primary outcome (such as ischemic stroke and major bleeding) were assessed as secondary outcomes.

Results: Of the 840 adults randomized, the mean age was 64 (SD, 8) years, 24.9% were women, the mean CHA2DS2-VASc score was 2.1 (SD, 1.0), and 67.6% had paroxysmal AF. At 2 years, the primary outcome occurred in 1 patient (0.3%) in the discontinue oral anticoagulant therapy group vs 8 patients (2.2%) in the continue oral anticoagulant therapy group (absolute difference, -1.9 percentage points [95% CI, -3.5 to -0.3]; P = .02). The 2-year cumulative incidence of ischemic stroke was 0.3% in the discontinue oral anticoagulant therapy group vs 0.8% in the continue oral anticoagulant therapy group (absolute difference, -0.5 percentage points [95% CI, -1.6 to 0.6]). Major bleeding occurred in 0 patients in the discontinue oral anticoagulant therapy group vs 5 patients (1.4%) in the continue oral anticoagulant therapy group (absolute difference, -1.4 percentage points [95% CI, -2.6 to -0.2]).

Conclusions and relevance: Among patients without documented atrial arrhythmia recurrence after catheter ablation for AF, discontinuing oral anticoagulant therapy resulted in a lower risk for the composite outcome of stroke, systemic embolism, and major bleeding vs continuing direct oral anticoagulant therapy.

Trial registration: ClinicalTrials.gov Identifier: NCT04432220.

Author/s:

Daehoon Kim, MD, Jaemin Shim, MD, Eue-Keun Choi, MD

Aspirin Use to Prevent Cardiovascular Disease US Preventive Services Task Force Recommendation Statement

Saige Blanchard — Tue, 10 May 2022 05:00:00 +0000

Date Added:

May 10, 2022

Journal/Publication:

Journal of the American Medical Association

Publisher:

American Medical Association

Publication Date:

April 26, 2022

Issue:

Volume:

327

Pages:

1577-1584

URL:

Aspirin Use to Prevent Cardiovascular Disease US Preventive Services Task Force Recommendation Statement

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1001/jama.2022.4983

Keywords

aspirin

cardiovascular disease

USPSTF

mortality

PMID (1):

35471505

MeSH

Adult

Cardiovascular Disease

incidence

Ulcer

primary prevention

Current USPSTF recommendations regarding the use of low-dose aspirin for primary prevention of adverse cardiovascular events. James W. Mold, MD, MPH

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Importance: Cardiovascular disease (CVD) is the leading cause of mortality in the US, accounting for more than 1 in 4 deaths. Each year, an estimated 605 000 people in the US have a first myocardial infarction and an estimated 610 000 experience a first stroke.

Objective: To update its 2016 recommendation, the US Preventive Services Task Force (USPSTF) commissioned a systematic review on the effectiveness of aspirin to reduce the risk of CVD events (myocardial infarction and stroke), cardiovascular mortality, and all-cause mortality in persons without a history of CVD. The systematic review also investigated the effect of aspirin use on colorectal cancer (CRC) incidence and mortality in primary CVD prevention populations, as well as the harms (particularly bleeding) associated with aspirin use. The USPSTF also commissioned a microsimulation modeling study to assess the net balance of benefits and harms from aspirin use for primary prevention of CVD and CRC, stratified by age, sex, and CVD risk level.

Population: Adults 40 years or older without signs or symptoms of CVD or known CVD (including history of myocardial infarction or stroke) who are not at increased risk for bleeding (eg, no history of gastrointestinal ulcers, recent bleeding, other medical conditions, or use of medications that increase bleeding risk).

Evidence assessment: The USPSTF concludes with moderate certainty that aspirin use for the primary prevention of CVD events in adults aged 40 to 59 years who have a 10% or greater 10-year CVD risk has a small net benefit. The USPSTF concludes with moderate certainty that initiating aspirin use for the primary prevention of CVD events in adults 60 years or older has no net benefit.

Recommendation: The decision to initiate low-dose aspirin use for the primary prevention of CVD in adults aged 40 to 59 years who have a 10% or greater 10-year CVD risk should be an individual one. Evidence indicates that the net benefit of aspirin use in this group is small. Persons who are not at increased risk for bleeding and are willing to take low-dose aspirin daily are more likely to benefit. (C recommendation) The USPSTF recommends against initiating low-dose aspirin use for the primary prevention of CVD in adults 60 years or older. (D recommendation).

Author/s:

US Preventive Services Task Force

Diagnosis of Lyme Disease

Saige Blanchard — Thu, 10 Mar 2022 06:00:00 +0000

Date Added:

March 10, 2022

Journal/Publication:

Journal of the American Medical Association

Publisher:

American Medical Association

URL:

Diagnosis of Lyme Disease

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1001/jama.2022.0081

Keywords

MeSH

While there have been very few documented cases of Lyme disease in Oklahoma, diagnostic testing is often considered. This is a concise summary of the evidence regarding diagnostic tests for Lyme disease and how and when to use or not use them. James W. Mold, MD, MPH

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Lyme disease is the most common tick-borne illness in the US, occurring predominantly in the Northeast, the upper Midwest, and Northern California, with increasing incidence and geographic range.1 Lyme disease can cause a skin lesion at the site of the initial tick bite as well as disseminated disease, including neuropathy, meningitis, acute myocarditis/pericarditis (often with associated conduction abnormalities), and arthritis. Accurate diagnosis is the first step in the optimal management of Lyme disease.

Author/s:

Pitrak, D, Nguyen, C. T., Cifu, A. S.

Corticosteroid Use and Risk of Herpes Zoster in a Population-Based Cohort

Saige Blanchard — Mon, 03 Jan 2022 06:00:00 +0000

Date Added:

January 3, 2022

Journal/Publication:

Mayo Clinic Proceedings

Publisher:

Mayo Foundation for Medical Education and Research

Publication Date:

November 1, 2021

Issue:

Volume:

Pages:

2843-2853

URL:

Corticosteroid Use and Risk of Herpes Zoster in a Population-Based Cohort

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1016/j.mayocp.2021.05.029

Keywords

Cohort

corticosteroids

Herpes zoster

PMID (1):

34736610

MeSH

Humans

aged

incidence

Proportional Hazards Models

cyclo(Arg-Pro)

Herpes Zoster

Not surprisingly, systemic corticosteroid use increases the risk of herpes zoster. James W. Mold, MD, MPH

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Objective: To examine the relationship between corticosteroid use and herpes zoster risk.

Methods: With data from a large cohort of adults (the 45 and Up Study) recruited between 2006 and 2009 and linked to health data sets, the effect of corticosteroid use on zoster risk was analyzed by Cox proportional hazards models, adjusting for age, sex, and other characteristics.

Results: During 602,152 person-years (median, 7.36 years) of follow-up, there were 20,048 new systemic corticosteroid users and 6294 incident herpes zoster events among 94,677 participants (zoster incidence, 11.0 per 1000 person-years). Compared with nonusers, the risk of zoster was 59% higher in those using systemic corticosteroids (adjusted hazard ratio [aHR], 1.59; 95% CI, 1.48 to 1.71) and greater with higher cumulative doses: aHR of 1.32 (95% CI, 1.17 to 1.48), 1.74 (95% CI, 1.55 to 1.95), and 1.80 (95% CI, 1.61 to 2.02) for use of less than 500 mg, 500 mg to less than 1000 mg, and 1000 mg or more prednisolone equivalents, respectively (P value for trend, <.001). Compared with nonusers, zoster risk increased significantly (aHR, 6.00; 95% CI, 4.85 to 7.42) in the month after a single prescription of systemic corticosteroids and returned to levels similar to those in nonusers by the third month after dispensing (aHR, 0.91; 95% CI, 0.49 to 1.69).

Conclusion: Practitioners should be alert to the increased risk of zoster among patients taking systemic corticosteroids. Given the significant morbidity from zoster, particularly in older adults, these findings support judicious prescribing of corticosteroids, including using as low a dose and as short a course as possible.

Keywords: Cohort; Corticosteroids; Herpes zoster.

Author/s:

Qian, J., Banks, E., Macartney, K., Heywood, A. E., Lassere, M. N., Liu, B.

Short-term and Long-term Rates of Postacute Sequelae of SARS-CoV-2 Infection: A Systematic Review

Bethie Seay — Sun, 07 Nov 2021 05:00:00 +0000

Date Added:

November 7, 2021

Journal/Publication:

JAMA Network Open

Publication Date:

October 13, 2021

Issue:

Volume:

Pages:

e2128568

Type:

Meta-analyses, Reviews, and Guidelines

DOI (1):

10.1001/jamanetworkopen.2021.28568

A summary of post-COVID symptoms and their duration based upon studies involving more than 250,000 cases.

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Importance
Short-term and long-term persistent postacute sequelae of COVID-19 (PASC) have not been systematically evaluated. The incidence and evolution of PASC are dependent on time from infection, organ systems and tissue affected, vaccination status, variant of the virus, and geographic region.

Objective
To estimate organ system–specific frequency and evolution of PASC.

Evidence Review
PubMed (MEDLINE), Scopus, the World Health Organization Global Literature on Coronavirus Disease, and CoronaCentral databases were searched from December 2019 through March 2021. A total of 2100 studies were identified from databases and through cited references. Studies providing data on PASC in children and adults were included. The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines for abstracting data were followed and performed independently by 2 reviewers. Quality was assessed using the Newcastle-Ottawa Scale for cohort studies. The main outcome was frequency of PASC diagnosed by (1) laboratory investigation, (2) radiologic pathology, and (3) clinical signs and symptoms. PASC were classified by organ system, ie, neurologic; cardiovascular; respiratory; digestive; dermatologic; and ear, nose, and throat as well as mental health, constitutional symptoms, and functional mobility.

Findings
From a total of 2100 studies identified, 57 studies with 250 351 survivors of COVID-19 met inclusion criteria. The mean (SD) age of survivors was 54.4 (8.9) years, 140 196 (56%) were male, and 197 777 (79%) were hospitalized during acute COVID-19. High-income countries contributed 45 studies (79%). The median (IQR) proportion of COVID-19 survivors experiencing at least 1 PASC was 54.0% (45.0%-69.0%; 13 studies) at 1 month (short-term), 55.0% (34.8%-65.5%; 38 studies) at 2 to 5 months (intermediate-term), and 54.0% (31.0%-67.0%; 9 studies) at 6 or more months (long-term). Most prevalent pulmonary sequelae, neurologic disorders, mental health disorders, functional mobility impairments, and general and constitutional symptoms were chest imaging abnormality (median [IQR], 62.2% [45.8%-76.5%]), difficulty concentrating (median [IQR], 23.8% [20.4%-25.9%]), generalized anxiety disorder (median [IQR], 29.6% [14.0%-44.0%]), general functional impairments (median [IQR], 44.0% [23.4%-62.6%]), and fatigue or muscle weakness (median [IQR], 37.5% [25.4%-54.5%]), respectively. Other frequently reported symptoms included cardiac, dermatologic, digestive, and ear, nose, and throat disorders.

Conclusions and Relevance
In this systematic review, more than half of COVID-19 survivors experienced PASC 6 months after recovery. The most common PASC involved functional mobility impairments, pulmonary abnormalities, and mental health disorders. These long-term PASC effects occur on a scale that could overwhelm existing health care capacity, particularly in low- and middle-income countries.

Author/s:

Groff, D., Sun, A., Ssentongo, A. E., Ba, D. M., Parsons, N., Poudel, G. R., Lekoubou, A., Oh, J. S., Ericson, J. E., Ssentongo, P., Chinchilli, V. M.

Incidence, co-occurrence, and evolution of long-COVID features: A 6-month retrospective cohort study of 273,618 survivors of COVID-19

Bethie Seay — Tue, 05 Oct 2021 05:00:00 +0000

Date Added:

October 5, 2021

Journal/Publication:

PLOS Medicine

Publication Date:

September 28, 2021

Issue:

Volume:

Type:

Clinical Research Results

DOI (1):

10.1371/journal.pmed.1003773

An assessment of the epidemiology and characteristics of long COVID syndrome from nearly 275,000 linked electronic records.

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Background
Long-COVID refers to a variety of symptoms affecting different organs reported by people following Coronavirus Disease 2019 (COVID-19) infection. To date, there have been no robust estimates of the incidence and co-occurrence of long-COVID features, their relationship to age, sex, or severity of infection, and the extent to which they are specific to COVID-19. The aim of this study is to address these issues.

Methods and findings
We conducted a retrospective cohort study based on linked electronic health records (EHRs) data from 81 million patients including 273,618 COVID-19 survivors. The incidence and co-occurrence within 6 months and in the 3 to 6 months after COVID-19 diagnosis were calculated for 9 core features of long-COVID (breathing difficulties/breathlessness, fatigue/malaise, chest/throat pain, headache, abdominal symptoms, myalgia, other pain, cognitive symptoms, and anxiety/depression). Their co-occurrence network was also analyzed. Comparison with a propensity score–matched cohort of patients diagnosed with influenza during the same time period was achieved using Kaplan–Meier analysis and the Cox proportional hazard model. The incidence of atopic dermatitis was used as a negative control.

Among COVID-19 survivors (mean [SD] age: 46.3 [19.8], 55.6% female), 57.00% had one or more long-COVID feature recorded during the whole 6-month period (i.e., including the acute phase), and 36.55% between 3 and 6 months. The incidence of each feature was: abnormal breathing (18.71% in the 1- to 180-day period; 7.94% in the 90- to180-day period), fatigue/malaise (12.82%; 5.87%), chest/throat pain (12.60%; 5.71%), headache (8.67%; 4.63%), other pain (11.60%; 7.19%), abdominal symptoms (15.58%; 8.29%), myalgia (3.24%; 1.54%), cognitive symptoms (7.88%; 3.95%), and anxiety/depression (22.82%; 15.49%). All 9 features were more frequently reported after COVID-19 than after influenza (with an overall excess incidence of 16.60% and hazard ratios between 1.44 and 2.04, all p < 0.001), co-occurred more commonly, and formed a more interconnected network. Significant differences in incidence and co-occurrence were associated with sex, age, and illness severity. Besides the limitations inherent to EHR data, limitations of this study include that (i) the findings do not generalize to patients who have had COVID-19 but were not diagnosed, nor to patients who do not seek or receive medical attention when experiencing symptoms of long-COVID; (ii) the findings say nothing about the persistence of the clinical features; and (iii) the difference between cohorts might be affected by one cohort seeking or receiving more medical attention for their symptoms.

Conclusions
Long-COVID clinical features occurred and co-occurred frequently and showed some specificity to COVID-19, though they were also observed after influenza. Different long-COVID clinical profiles were observed based on demographics and illness severity.

Author summary
Why was this study done?
Long-COVID has been described in recent studies. But we do not know the risk of developing features of this condition and how it is affected by factors such as age, sex, or severity of infection.
We do not know if the risk of having features of long-COVID is more likely after Coronavirus Disease 2019 (COVID-19) than after influenza.
We do not know about the extent to which different features of long-COVID co-occur.
What did the researchers do and find?
This research used data from electronic health records of 273,618 patients diagnosed with COVID-19 and estimated the risk of having long-COVID features in the 6 months after a diagnosis of COVID-19. It compared the risk of long-COVID features in different groups within the population and also compared the risk to that after influenza.
The research found that over 1 in 3 patients had one or more features of long-COVID recorded between 3 and 6 months after a diagnosis of COVID-19. This was significantly higher than after influenza.
For 2 in 5 of the patients who had long-COVID features in the 3- to 6-month period, they had no record of any such feature in the previous 3 months.
The risk of long-COVID features was higher in patients who had more severe COVID-19 illness, and slightly higher among females and young adults. White and non-white patients were equally affected.
What do these findings mean?
Knowing the risk of long-COVID features helps in planning the relevant healthcare service provision.
The fact that the risk is higher after COVID-19 than after influenza suggests that their origin might, in part, directly involve infection with SARS-CoV-2 and is not just a general consequence of viral infection. This might help in developing effective treatments against long-COVID.
The findings in the subgroups, and the fact that the majority of patients who have features of long-COVID in the 3- to 6-month period already had symptoms in the first 3 months, may help in identifying those at greatest risk.

Author/s:

Taquet, M., Dercon, Q., Luciano, S., Geddes, J. R., Husain, M., Harrison, P. J.

Screening for Colorectal Cancer US Preventive Services Task Force Recommendation Statement

Saige Blanchard — Fri, 21 May 2021 05:00:00 +0000

Date Added:

May 21, 2021

Journal/Publication:

Journal of the American Medical Association

Publisher:

American Medical Association

Publication Date:

May 18, 2021

Issue:

Volume:

325

Pages:

1965-1977

URL:

Screening for Colorectal Cancer US Preventive Services Task Force Recommendation Statement

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1001/jama.2021.6238

Keywords

PMID (1):

34003218

MeSH

Colorectal Neoplasms

hereditary nonpolyposis

incidence

Mass Screening

intestinal polyposis

Updated USPSTF recommendations regarding CRC screening. James W. Mold, MD, MPH

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Abstract

Importance: Colorectal cancer is the third leading cause of cancer death for both men and women, with an estimated 52 980 persons in the US projected to die of colorectal cancer in 2021. Colorectal cancer is most frequently diagnosed among persons aged 65 to 74 years. It is estimated that 10.5% of new colorectal cancer cases occur in persons younger than 50 years. Incidence of colorectal cancer (specifically adenocarcinoma) in adults aged 40 to 49 years has increased by almost 15% from 2000-2002 to 2014-2016. In 2016, 26% of eligible adults in the US had never been screened for colorectal cancer and in 2018, 31% were not up to date with screening.

Objective: To update its 2016 recommendation, the US Preventive Services Task Force (USPSTF) commissioned a systematic review to evaluate the benefits and harms of screening for colorectal cancer in adults 40 years or older. The review also examined whether these findings varied by age, sex, or race/ethnicity. In addition, as in 2016, the USPSTF commissioned a report from the Cancer Intervention and Surveillance Modeling Network Colorectal Cancer Working Group to provide information from comparative modeling on how estimated life-years gained, colorectal cancer cases averted, and colorectal cancer deaths averted vary by different starting and stopping ages for various screening strategies.

Population: Asymptomatic adults 45 years or older at average risk of colorectal cancer (ie, no prior diagnosis of colorectal cancer, adenomatous polyps, or inflammatory bowel disease; no personal diagnosis or family history of known genetic disorders that predispose them to a high lifetime risk of colorectal cancer [such as Lynch syndrome or familial adenomatous polyposis]).

Evidence assessment: The USPSTF concludes with high certainty that screening for colorectal cancer in adults aged 50 to 75 years has substantial net benefit. The USPSTF concludes with moderate certainty that screening for colorectal cancer in adults aged 45 to 49 years has moderate net benefit. The USPSTF concludes with moderate certainty that screening for colorectal cancer in adults aged 76 to 85 years who have been previously screened has small net benefit. Adults who have never been screened for colorectal cancer are more likely to benefit.

Recommendation: The USPSTF recommends screening for colorectal cancer in all adults aged 50 to 75 years. (A recommendation) The USPSTF recommends screening for colorectal cancer in adults aged 45 to 49 years. (B recommendation) The USPSTF recommends that clinicians selectively offer screening for colorectal cancer in adults aged 76 to 85 years. Evidence indicates that the net benefit of screening all persons in this age group is small. In determining whether this service is appropriate in individual cases, patients and clinicians should consider the patient's overall health, prior screening history, and preferences. (C recommendation).

Author/s:

Davidson, K. W., Barry, M. J., Mangione, C. M., Cabana, M., Caughey, A. B., Davis, E. M., Donahue, K. E., Doubeni, C. A., Krist, A. H., Kubik, M., Li, L., Ogedegbe, G., Owens, D. K., Pbert, L., Silverstein, M., Stevermer, J., Tseng, C., Wong, J. B.

Association of Menopausal Hormone Therapy With Breast Cancer Incidence and Mortality During Long-term Follow-up of the Women's Health Initiative Randomized Clinical Trials

Brian Desmarais — Mon, 03 Aug 2020 15:08:08 +0000

Date Added:

August 3, 2020

Journal/Publication:

Journal of the American Medical Association

Publication Date:

July 28, 2020

Issue:

Volume:

324

Pages:

368-380

URL:

Association of Menopausal Hormone Therapy With Breast Cancer Incidence and Mortality During Long-term Follow-up of the Women's Health Initiative Randomized Clinical Trials

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1001/jama.2020.9482.

MeSH

Association of HRT and breast cancer. James W. Mold, MD, MPH

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Abstract

Importance: The influence of menopausal hormone therapy on breast cancer remains unsettled with discordant findings from observational studies and randomized clinical trials.

Objective: To assess the association of prior randomized use of estrogen plus progestin or prior randomized use of estrogen alone with breast cancer incidence and mortality in the Women's Health Initiative clinical trials.

Design, setting, and participants: Long-term follow-up of 2 placebo-controlled randomized clinical trials that involved 27 347 postmenopausal women aged 50 through 79 years with no prior breast cancer and negative baseline screening mammogram. Women were enrolled at 40 US centers from 1993 to 1998 with follow-up through December 31, 2017.

Interventions: In the trial involving 16 608 women with a uterus, 8506 were randomized to receive 0.625 mg/d of conjugated equine estrogen (CEE) plus 2.5 mg/d of medroxyprogesterone acetate (MPA) and 8102, placebo. In the trial involving 10 739 women with prior hysterectomy, 5310 were randomized to receive 0.625 mg/d of CEE alone and 5429, placebo. The CEE-plus-MPA trial was stopped in 2002 after 5.6 years' median intervention duration, and the CEE-only trial was stopped in 2004 after 7.2 years' median intervention duration.

Main outcomes and measures: The primary outcome was breast cancer incidence (protocol prespecified primary monitoring outcome for harm) and secondary outcomes were deaths from breast cancer and deaths after breast cancer.

Results: Among 27 347 postmenopausal women who were randomized in both trials (baseline mean [SD] age, 63.4 years [7.2 years]), after more than 20 years of median cumulative follow-up, mortality information was available for more than 98%. CEE alone compared with placebo among 10 739 women with a prior hysterectomy was associated with statistically significantly lower breast cancer incidence with 238 cases (annualized rate, 0.30%) vs 296 cases (annualized rate, 0.37%; hazard ratio [HR], 0.78; 95% CI, 0.65-0.93; P = .005) and was associated with statistically significantly lower breast cancer mortality with 30 deaths (annualized mortality rate, 0.031%) vs 46 deaths (annualized mortality rate, 0.046%; HR, 0.60; 95% CI, 0.37-0.97; P = .04). In contrast, CEE plus MPA compared with placebo among 16 608 women with a uterus was associated with statistically significantly higher breast cancer incidence with 584 cases (annualized rate, 0.45%) vs 447 cases (annualized rate, 0.36%; HR, 1.28; 95% CI, 1.13-1.45; P < .001) and no significant difference in breast cancer mortality with 71 deaths (annualized mortality rate, 0.045%) vs 53 deaths (annualized mortality rate, 0.035%; HR, 1.35; 95% CI, 0.94-1.95; P= .11).

Conclusions and relevance:

In this long-term follow-up study of 2 randomized trials, prior randomized use of CEE alone, compared with placebo, among women who had a previous hysterectomy, was significantly associated with lower breast cancer incidence and lower breast cancer mortality, whereas prior randomized use of CEE plus MPA, compared with placebo, among women who had an intact uterus, was significantly associated with a higher breast cancer incidence but no significant difference in breast cancer mortality.

Author/s:

Chlebowski, R.T., Anderson, G.L., Aragaki, A.K., Manson, J.E., Stefanick, M.L., Pan, K., Barrington, W., Kuller, K.H., Simon, M.S., Lane, D., Johnson, K.C., Rohan, T.E., Gass, M.L.S., Cauler, C.A., Paskett, E.D., Sattari, M., Prentice, M.L.

Association Between Age and Complications After Outpatient Colonoscopy

Brian Desmarais — Mon, 29 Jun 2020 16:48:40 +0000

Date Added:

June 29, 2020

Journal/Publication:

JAMA network open

Publisher:

Journal of American Medical Association

Publication Date:

June 1, 2020

URL:

Association Between Age and Complications After Outpatient Colonoscopy

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1001/jamanetworkopen.2020.8958

MeSH

renal insufficiency, chronic

hospitalization

Inflammatory Bowel Diseases

early detection of cancer

risk factors

cohort studies

incidence

retrospective studies

The risk of major complications of colonoscopy is greater for liver disease (odds ratio [OR], 4.7; 95% CI, 3.5-6.5) smokers (OR, 3.2; 95% CI, 2.4-4.3), patients who are obese (OR, 2.3; 95% CI, 1.2-4.2), and patients who are over 75 years of age (OR, 2.3; 95% CI, 2.0-2.6). James W. Mold, MD, MPH

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Abstract

Importance: There are insufficient data describing the incidence and risk factors of postcolonoscopy complications in older individuals.

Objective: To assess the association between older age (≥75 years) and the risk of postcolonoscopy complications.

Design, setting, and participants: This population-based retrospective cohort study included adults (≥50 years) undergoing outpatient colonoscopy between April 2008 and September 2017, identified from Ontario administrative databases. Individuals with inflammatory bowel disease and hereditary colorectal cancer syndromes were excluded. The study population was subdivided into a colorectal cancer screening-eligible cohort (patients aged 50-74 years) and an older cohort (patients aged ≥75 years). The statistical analysis was conducted from December 2018 to September 2019.

Exposures: Older age (≥75 years).

Main outcomes and measures: The primary outcome was postcolonoscopy complications, defined as the composite of hospitalization or emergency department visits in the 30-day period after the outpatient colonoscopy. Secondary outcomes included incidence of surgically treated colorectal cancer and all-cause mortality at 30 days. Independent variables associated with postcolonoscopy complications were also assessed.

Results: The study sample included 38 069 patients; the mean (SD) age was 65.2 (10.1) years, there were 19 037 women (50.0%), and 27 831 patients (73.1%) underwent a first colonoscopy. The cumulative incidence of complications was 3.4% (1310 patients) in the overall population, and it was higher in individuals aged 75 years or older (515 of 7627 patients [6.8%]) than in screening-eligible cohort (795 of 30 443 patients [2.6%]) (P < .001). Independent risk factors for postcolonoscopy complications were age 75 years or older (odds ratio [OR], 2.3; 95% CI, 2.0-2.6), anemia (OR, 1.4; 95% CI, 1.2-1.7), cardiac arrhythmia (OR, 1.7; 95% CI, 1.2-2.2), congestive heart failure (OR, 3.4; 95% CI, 2.5-4.6), hypertension (OR, 1.2; 95% CI, 1.0-1.5), chronic kidney disease (OR, 1.8; 95% CI, 1.1-3.0), liver disease (OR, 4.7; 95% CI, 3.5-6.5), smoking history (OR, 3.2; 95% CI, 2.4-4.3), and obesity (OR, 2.3; 95% CI, 1.2-4.2). The number of previous colonoscopies was associated with a lower risk of complications (OR, 0.9; 95% CI, 0.7-1.0). The incidence of surgically treated colorectal cancer was higher in the older cohort than the screening-eligible cohort (119 patients [1.6%] vs 144 patients [0.5%]; P < .001). All-cause mortality rates were 0.1% overall (39 patients) and 0.1% (19 patients) for individuals aged 50 to 74 years and 0.2% (20 patients) for those aged 75 years and older (P < .001).

Conclusions and relevance: In this population-based cohort study of individuals living in southern Ontario, age of 75 years and older was associated with a higher risk of 30-day postprocedure complications after outpatient colonoscopy. These findings suggest that the decision to perform a colonoscopy should be carefully considered in patients older than 75 years, especially in the presence of comorbidities. Further studies are needed to better understand the benefits of invasive procedures as opposed to less invasive approaches for colorectal cancer screening and surveillance among older patients.

Author/s:

Causada-Calo, N., Bishay, K., Albashir, S., Mazroui, A.A., Armstrong, D.

Effectiveness of a Mouth Care Program Provided by Nursing Home Staff vs Standard Care on Reducing Pneumonia Incidence: A Cluster Randomized Trial

Brian Desmarais — Mon, 22 Jun 2020 15:39:47 +0000

Date Added:

June 22, 2020

Journal/Publication:

JAMA Network Open

Publisher:

American Medical Association

Publication Date:

June 1, 2020

Issue:

Volume:

URL:

Effectiveness of a Mouth Care Program Provided by Nursing Home Staff vs Standard Care on Reducing Pneumonia Incidence: A Cluster Randomized Trial

Type:

Clinical Research Results

Format:

Article

DOI (1):

https://doi.org/10.1001/jamanetworkopen.2020.4321

Keywords

MeSH

The organisms responsible for pneumonia live in the mouth. Technically, nearly all pneumonias are due to aspiration. At least one RCT in Japan showed that excellent oral hygiene (by dental hygienists) in NHs can reduce the incidence of pneumonia. This study showed that enhanced oral hygiene performed by nurses reduced pneumonia episodes for the first year, and then the effect waned. James W. Mold, MD, MPH

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Abstract

Importance: Pneumonia affects more than 250 000 nursing home (NH) residents annually. A strategy to reduce pneumonia is to provide daily mouth care, especially to residents with dementia.

Objective: To evaluate the effectiveness of Mouth Care Without a Battle, a program that increases staff knowledge and attitudes regarding oral hygiene, changes mouth care, and improves oral hygiene, in reducing the incidence of pneumonia among NH residents.

Design, setting, and participants: This pragmatic cluster randomized trial observing 2152 NH residents for up to 2 years was conducted from September 2014 to May 2017. Data collectors were masked to study group. The study included 14 NHs from regions of North Carolina that evidenced proportionately high rehospitalization rates for pneumonia and long-term care residents. Nursing homes were pair matched and randomly assigned to intervention or control groups.

Intervention: Mouth Care Without a Battle is a standardized program that teaches that mouth care is health care, provides instruction on individualized techniques and products for mouth care, and trains caregivers to provide care to residents who are resistant and in special situations. The control condition was standard mouth care.

Main outcomes and measures: Pneumonia incidence (primary) and hospitalization and mortality (secondary), obtained from medical records.

Results: Overall, the study enrolled 2152 residents (mean [SD] age, 79.4 [12.4] years; 1281 [66.2%] women; 1180 [62.2%] white residents). Participants included 1219 residents (56.6%) in 7 intervention NHs and 933 residents (43.4%) in 7 control NHs. During the 2-year study period, the incidence rate of pneumonia per 1000 resident-days was 0.67 and 0.72 in the intervention and control NHs, respectively. Neither the primary (unadjusted) nor secondary (covariate-adjusted) analyses found a significant reduction in pneumonia due to Mouth Care Without a Battle during 2 years (unadjusted incidence rate ratio, 0.90; upper bound of 1-sided 95% CI, 1.24; P = .27; adjusted incidence rate ratio, 0.92; upper bound of 1-sided 95% CI, 1.27; P = .30). In the second year, the rate of pneumonia was nonsignificantly higher in intervention NHs. Adjusted post hoc analyses limited to the first year found a significant reduction in pneumonia incidence in intervention NHs (IRR, 0.69; upper bound of 1-sided 95% CI, 0.94; P = .03).

Conclusions and relevance: This matched-pairs cluster randomized trial of a mouth care program compared with standard care was not effective in reducing pneumonia incidence at 2 years, although reduction was found during the first year. The lack of significant results in the second year may be associated with sustainability. Improving mouth care in US NHs may require the presence and support of dedicated oral care aides.

Author/s:

Zimmerman, S., Sloane, P.D., Ward, K., Wretman, C.J., Stearns, S.C., Poole, P., Preisser, J.S.

Return to Sport Following Adolescent Concussion: Epidemiologic Findings From a High School Population

Brian Desmarais — Thu, 18 Jun 2020 18:52:31 +0000

Date Added:

June 18, 2020

Journal/Publication:

Orthopedics

Publication Date:

June 4, 2020

URL:

Return to Sport Following Adolescent Concussion: Epidemiologic Findings From a High School Population

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.3928/01477447-20200521-03

MeSH

Adolescent athletes with concussion require an average of 1 month recovery time before they are ready to return to their sport. James W. Mold, MD, MPH

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Abstract

High school athletes sustaining a concussion require careful attention when determining return-to-sport (RTS) readiness. The purpose of this study was to determine epidemiological and RTS data of a large cohort of high school athletes who sustained 1 or more concussions. Records of 357 consecutive youth patients who sustained concussions and presented to a single health care system between September 2013 and December 2016 were reviewed. Demographic data, RTS, and concussion-related variables were obtained via chart review. Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) scores at baseline and following concussions were performed by neuropsychologists. The average age at injury was 15.5 years (range, 14-18 years), 61.9% of patients were male, 6.7% reported a loss of consciousness, and 14.3% reported amnesia, requiring 30.4±23.3 days of recovery prior to RTS. The most common sport of injury was football (27.7%). There was a high incidence of previous concussion (33.1%), and 32 athletes sustained a recurrent concussion. A multivariate model demonstrated that females, players with a history of concussion, and those diagnosed in-clinic rather than in-game required increased time to RTS. Memory ImPACT scores were found to increase as players had recurrent concussions. Visual motor speed and reaction time scores decreased with recurrent concussions. [Orthopedics. 2020;43(x):xx-xx.].

Author/s:

Jildeh, T.R., Okoroha, K.R., Denha, E., Eyers, C., Johnson, A., Shehab, R.

Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis

Brian Desmarais — Wed, 03 Jun 2020 14:42:13 +0000

Date Added:

June 3, 2020

Journal/Publication:

New England Journal of Medicine

Publication Date:

May 14, 2020

Issue:

Volume:

382

Pages:

1906-1915

URL:

Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1056/NEJMoa1915254

MeSH

Lactobacillus crispatus

Vaginosis, Bacterial

Societies, Medical

Administration, Intravaginal

risk factors

random allocation

Intention to Treat Analysis

follow-up studies

double-blind method

Confidence Intervals

anti-bacterial agents

incidence

Odds Ratio

RPR Commentary: This RCT suggest that intravaginal Lactin V (a probiotic) delayed recurrence of bacterial vaginosis in women following treatment with metronidazole. James W. Mold, MD, MPH

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Abstract

Background: Bacterial vaginosis affects 15 to 50% of women of reproductive age, and recurrence is common after treatment with an antibiotic agent. The high incidence of recurrence suggests the need for new treatments to prevent recurrent bacterial vaginosis.

Methods: We conducted a randomized, double-blind, placebo-controlled, phase 2b trial to evaluate the ability of Lactobacillus crispatus CTV-05 (Lactin-V) to prevent the recurrence of bacterial vaginosis. Women 18 to 45 years of age who had received a diagnosis of bacterial vaginosis and who had completed a course of vaginal metronidazole gel as part of the eligibility requirements were randomly assigned, in a 2:1 ratio, to receive vaginally administered Lactin-V or placebo for 11 weeks; follow-up occurred through week 24. The primary outcome was the percentage of women who had a recurrence of bacterial vaginosis by week 12.

Results: A total of 228 women underwent randomization: 152 to the Lactin-V group and 76 to the placebo group; of these participants, 88% in the Lactin-V group and 84% in the placebo group could be evaluated for the primary outcome. In the intention-to-treat population, recurrence of bacterial vaginosis by week 12 occurred in 46 participants (30%) in the Lactin-V group and in 34 participants (45%) in the placebo group (risk ratio after multiple imputation for missing responses, 0.66; 95% confidence interval [CI], 0.44 to 0.87; P = 0.01). The risk ratio for recurrence by week 24 (also calculated with multiple imputation for missing responses) was 0.73 (95% CI, 0.54 to 0.92). At the 12-week visit, L. crispatus CTV-05 was detected in 79% of participants in the Lactin-V group. The percentage of participants who had at least one adverse event related to Lactin-V or placebo by week 24 did not differ significantly between the groups. The percentage of participants with local or systemic adverse events was similar in the two groups.

Conclusions: The use of Lactin-V after treatment with vaginal metronidazole resulted in a significantly lower incidence of recurrence of bacterial vaginosis than placebo at 12 weeks. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT02766023.).

Author/s:

Cohen, C.R., Wierzbicki, C.R., French, A.L., Morris, S., Newmann, S., Reno, H., Green, L., Miller, S., Powell, J., Parks, T., Hemmerling, S.

Aspirin for Primary Atherosclerotic Cardiovascular Disease Prevention as Baseline Risk Increases: A Meta-Regression Analysis

John Bayhi — Thu, 21 May 2020 16:39:36 +0000

Date Added:

May 21, 2020

Journal/Publication:

The American Journal of Medicine

Publisher:

Elsevier Inc

Publication Date:

May 20, 2020

Volume:

Article in Press

URL:

Aspirin for Primary Atherosclerotic Cardiovascular Disease Prevention as Baseline Risk Increases: A Meta-Regression Analysis

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1016/j.amjmed.2020.04.028

Keywords

aspirin

primary prevention

Atherosclerotic Cardiovascular Disease

myocardial infarction

MeSH

cardiovascular diseases

Brain Ischemia

follow-up studies

myocardial infarction

This analysis of 12 RCTs involving almost 1 million patients found that low-dose aspirin prevents major cardiovascular events (RRReduction 14%; ARR/1000 patient years 0.06%) but increases major bleeding events (RRIncrease 40%; ARR/1000 patient years 0.1%) across all levels of baseline risk. The researchers concluded that the absolute risk reduction and the risk: benefit ratio suggest that we should probably not prescribe low-dose aspirin for primary prevention even if the baseline risk of CV events is high and the risk of bleeding is low. James W. Mold, MD, MPH

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Background

Aspirin is often prescribed for the primary prevention of atherosclerotic cardiovascular disease (ASCVD) however, recent randomized trials (RCTs) have challenged this practice. Despite this, aspirin is commonly recommended for high risk primary prevention. We tested the hypothesis that aspirin is more efficacious for the primary prevention of ASCVD, as the baseline risk increases.

Methods

RCTs that compared aspirin to control for primary prevention and evaluated ASCVD (composite of myocardial infarction and ischemic stroke) and major bleeding were included. Rate ratios (RR) and 95% confidence intervals (CI) were calculated. A regression analysis was performed using the ASCVD event rate in the control arm of each RCT as the moderator.

Results

Twelve RCTs were identified with 963,829 patient years of follow-up. Aspirin was associated with a reduction in ASCVD (4.7 versus 5.3 events per 1,000 patient years; RR 0.86; 95% CI 0.79-0.92). There was increased major bleeding among aspirin users (2.5 versus 1.8 events per 1000 patient years, RR 1.41 95% CI, 1.29-1.54). Regression analysis found no relationship between the log rate ratio of ASCVD or major bleeding and incidence of ASCVD in the control arm of each RCT.

Conclusion

Aspirin is associated with a reduction in ASCVD when used for primary prevention; however, it is unlikely to be clinically significant given the increase in bleeding. More importantly, aspirin's treatment effect does not increase as ASCVD risk increases as many hypothesize. There is no suggestion from this data that use of aspirin for higher risk primary prevention patients is beneficial.

Author/s:

Nudy, M, Cooper, J, Ghahramani, M, Ruzieh, M, Mandrola, J, Foy, AJ