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SGLT-2 inhibitor, cardiovascular risk and outcome in patients with comorbidity of hypertension and diabetes [Cardiovascular disease]

Annals of Family Medicine

Sodium-glucose transporter 2 (SGLT-2) inhibitors have been proved to decrease the cardiovascular adverse events in several large randomized controlled trials (RCTS), but evidence limited to patients with type 2 diabetes and ASCVD. Setting or Dataset Five electronic systems of community clinic.

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Contraceptive counseling for gender-diverse patients: A community needs assessment [Health care disparities]

Annals of Family Medicine

Setting or Dataset: Potential participants accessed the survey using a QR code on an IRB-approved study flyer posted in the community, including in restaurants, stores, bars, and at Dallas Pride events. Additionally, the majority wanted the decision-aid to be inclusive of both gender-diverse and non-gender-diverse individuals.

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Adverse Outcomes Associated With Inhaled Corticosteroid Use in Individuals With Chronic Obstructive Pulmonary Disease [Original Research]

Annals of Family Medicine

METHODS We extracted electronic health record data for individuals aged >45 years with COPD from a data repository. RESULTS We assessed outcomes for 318,385 and 209,062 individuals in the prevalent and inception cohorts, respectively. 2.68; P < 001) and inception (HR = 2.60; 95% CI, 2.56-2.64;

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Extended duration of use of long-acting reversible contraceptives: Systematic review

Canadian Family Physician

Data sources A systematic search of MEDLINE, Embase, and Global Health electronic databases. Other adverse events were infrequent. Prolonged use of LARCs might be beneficial for individuals requiring contraception especially those with disrupted access to social and health care services or living in more remote areas.

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Exploring the educational needs and preferences of physicians in pharmacogenomics in primary care practice [Education and training]

Annals of Family Medicine

Context Ten percent of patients using prescription drugs experience adverse drug events (ADE). A proportion of these ADEs can be explained by a difference in enzyme activity between individuals. Intra-individual variation in genetic composition is one of the key contributing factors determining enzyme activity.

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eMDR System Enhancements

FDA Law

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time.

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How to Run DMC? It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials

FDA Law

Both documents discuss how membership should include individuals without conflicts of interest and with expertise in trial conduct, relevant clinical specialties, a qualified biostatistician, and a medical ethicist (in studies with greater risk).

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