Integrated Care News by CFHA

MAY 19, 2025

MBC is presented not simply as data collection, but as a dynamic, evidence-based clinical process that enhances outcomes, promotes equity, and strengthens team-based care. MBC supports optimal clinical practice, demonstrates the value of integrated care teams, and improves outcomes. What is MBC? 3, 4) Why is MBC important?

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Family Medicine Initiative

APRIL 9, 2024

Yes, one year after stopping the medication, patients regain ½ – ⅔ of their previous weight loss: What are other clinical benefits? 13 Here is some evidence: From 2004-2020, 8,718 GLP-1 analogs-associated tumors were reported to the FDA. Tirzepatide (15 mg) showed slightly more noticeable effects than Semaglutide (2.4

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The Medical Futurist

JUNE 21, 2025

billion people were living with vision loss in 2020, and it is forecasted to reach 1.7 Experts even say the eye is an ideal place to start for the first clinical use of CRISPR. How far can you see and hear? When it comes to vision, it’s around 50 miles, talking about hearing, it’s only 1-2 miles at best! How about touching or tasting?

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The Clinical Problem Solvers

JANUARY 18, 2021

Published December 2, 2020. Accessed December 9, 2020. 1:05:57 Outtakes Takeaways Name Racism for What It Is If we don’t explicitly say the word racism, and identify its historical context, then we are complicit in its denial. References Mentioned 01:55 Jones, C. Accessed January 11, 2021. 03:55 Jones, C. 16:20 Jones, CP.

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Annals of Family Medicine

MAY 27, 2025

METHODS We conducted semistructured interviews and focus groups with primary care staff (n = 16) and patients (n = 37) from primary care practices in northwest England and London (n = 14) using the Patchs eVisits system (Patchs Health Limited; www.patchs.ai ) from May 2020 to September 2021.

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FDA Law Blog

MARCH 29, 2024

In March 2020 , FDA temporarily postponed all foreign and domestic and routine surveillance facility inspections. According to GAO, FDA is facing challenges with clinical research inspections to ensure that the sites that oversee the research that lead to drug approvals meet the necessary standards. Claud & Kalie E.

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The Clinical Problem Solvers

MAY 9, 2021

The answer to this question may not be easily answered and may not always be found in the clinical setting. However it is important to remember that this political invention DOES affect biology because of the way that it creates social inequity. Pearls: “Genetics is not the end all be all of understanding disease” – Dorothy E.

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Annals of Family Medicine

NOVEMBER 20, 2024

Study Design: This retrospective case series analysis utilizes Vizient’s clinical database data. The study is divided into three periods: pre-COVID (Oct 2019 to Mar 2020), COVID (Apr 2020 to May 2023), and postCOVID (Jun 2023 to Dec 2023). Mixed models were used for analysis. Setting: AMCs within the US.

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Annals of Family Medicine

NOVEMBER 20, 2024

Study Design: This retrospective case series analysis utilizes Vizient’s clinical database data. The study is divided into three periods: pre-COVID (Oct 2019 to Mar 2020), COVID (Apr 2020 to May 2023), and post-COVID (Jun 2023 to Dec 2023). Mixed models were used for analysis. Setting: AMCs within the US.

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Annals of Family Medicine

NOVEMBER 20, 2024

RRSPUM includes 19 Academic Family Medicine clinics. In 2020, as our PBRN was expanding and because of the rapidly evolving Quebec Primary PC research landscape, we embarked on a strategic planning exercise. Objective: To better define the RRSPUM mission, vision and 5-year action plan. Setting: Université de Montréal DFMEM.

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Today's Hospitalist

MAY 9, 2025

Yet this expansion has come with a significant administrative burden, particularly that of clinical documentation. This isn’t about replacing your clinical judgment. Ambient dictation, or ambient clinical documentation, represents a paradigm shift. This isn’t about replacing your clinical judgment.

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Medical Xpress

MAY 9, 2023

She developed COVID-19 during the 2020 Christmas holiday and saw me during the summer of 2021. After months of waiting, she finally had an appointment at our post-COVID-19 clinic at the University of Virginia. A patient of mine, once a marathon runner, now gets tired just walking around the block. But exercise exhausted her.

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The Medical Futurist

MAY 18, 2025

Clinical use is already accepted, new FDA approvals and new trials are underway targeting new niches, like pediatric surgeries. They have started a large-scale clinical trial involving 10,000 patients, expected to last two years, with plans to obtain CE marking by the end of 2024. But there is undoubtedly impressive progress.

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The Clinical Problem Solvers

SEPTEMBER 15, 2021

[link] Dr. Titer, Dr. Williams, Maani and Lindsey discuss macro/microaggressions in the clinical setting. She has a passion for advancing diversity, equity and inclusion in graduate medical education and care delivery and was recognized as a recipient of the 2020 Dean’s Excellence Award in Diversity.

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Common Sense Family Doctor

DECEMBER 14, 2024

Concerns about overdiagnosis of clinically insignificant prostate cancer through prostate specific antigen (PSA) screening motivated the 2018 American Academy of Family Physicians’ (AAFP) recommendation against routine screening for prostate cancer. Watchful waiting refers to clinical observation only. A recent analysis of the U.S.

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FDA Law Blog

JUNE 14, 2021

Coincidentally, on the same day the post went up, Senator Rand Paul introduced the “Verified Innovative Testing in American Laboratories Act of 2020” or the “VITAL Act of 2020,” a new bill clarifying that the Centers for Medicare and Medicaid Services (CMS), not FDA, is to regulate LDTs. It was all decided by administrative fiat.

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The Clinical Problem Solvers

FEBRUARY 24, 2021

In contrast, scholarship and clinical care which acknowledges within-group differences and shifts from a deficit-based to an asset-based view of marginalized groups can help us better serve our minoritized patients. 2020 Nov; 396(10261): 1481-1482. Interpretations of ‘appropriate’ minority inclusion in clinical research.

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Noreta Family Medicine

FEBRUARY 12, 2025

Bill Skelton, founder of the Acupuncture Clinic here in Columbia, SC, gave me the film to watch and said he thought that as a Direct Primary Care physician and owner of Noreta Family Medicine, I would appreciate it. I ended up opening Noreta Family Medicine in 2020, a Direct Primary Care (DPC). minutes long.

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FDA Law Blog

MAY 4, 2023

Cato — On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices. In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories.

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FDA Law Blog

JANUARY 15, 2024

FDA complied with that order, later extended the deadline because of COVID, and eventually settled on a PMTA deadline of September 9, 2020. FDA complied with that order, later extended the deadline because of COVID, and eventually settled on a PMTA deadline of September 9, 2020.

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Common Sense Family Doctor

MARCH 15, 2025

Dr. Michelle Rockwell and colleagues at the Carilion Clinic in Roanoke, Virginia, performed a sludge audit of their colorectal cancer (CRC) screening services in 2021 and 2022. A sludge audit is “a systematic approach to identifying the presence and cost of sludge and figuring out how to eliminate it.”

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FDA Law Blog

FEBRUARY 26, 2024

But in 2020, a Citizen Petition came along looking to upend FDA’s approach to strength. Boehringer Ingelheim submitted a Citizen Petition in December 2020 encouraging FDA to interpret the term “strength” under the BPCIA differently than the Agency does under the Hatch-Waxman Act. Koblitz & Kurt R. do not help Boehringer’s case.

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The Clinical Problem Solvers

SEPTEMBER 19, 2024

Describe the positive impacts of qualitative methods on healthcare provision and/or policies in clinical settings. Mayo Clinic Proceedings: Innovations, Quality & Outcomes , 5 (5), 872–890. Health Equity Considerations in State Bills Related to Doula Care (2015–2020). During this episode, we hear from Dr. S. Karbeah, J.,

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FDA Law Blog

DECEMBER 7, 2022

However, while announcing in November 2020 that this endpoint was achieved, the sponsor shared that “[b]ased on interactions with the FDA and EMA,” it changed this primary endpoint for the trial to the co-primary endpoints of FIX activity and annualized bleeding rate (“ABR”), now measured at 52 weeks.

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FDA Law Blog

AUGUST 12, 2021

While Semglee was previously approved as a 505(b)(2) NDA referencing Lantus in June 2020, it was not rated as therapeutically equivalent (and therefore substitutable) to Lantus, and it immediately transitioned to a BLA upon approval as a result of the BPCIA (more on that below).

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PEMBlog

JUNE 14, 2023

Pediatrics October 2020; 146 (4): e20201174. 2020-1174 AAP-AACAP-CHA Declaration of a National Emergency in Child and Adolescent Mental Health Jennifer A. 2020-030692 Lo CB, Bridge JA, Shi J, Ludwig L, Stanley RM. 2020 Jun;145(6):e20191536. Epub 2020 May 11. McEnany, Olutosin Ojugbele, Julie R. Doherty, Jennifer L.

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The Clinical Problem Solvers

OCTOBER 18, 2022

Our guests remind us to think critically about our role in the carceral system and in imposing systems of control and punishment within clinical settings. Heard-Garris draws parallels between the culture within the carceral system and that within hospitals and clinics.

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CDOCS

MARCH 15, 2021

Patients depend on our clinical knowledge as well as our recommendations and relationships with our specialist partners.</span></span></p> Educate yourself, teams, and offices you work with so that you are able to communicate the clinical value in an honest, believable way,&rdquo; says Dr. Nelson.</span></span></p>

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BMJ

AUGUST 20, 2021

doi: 10.1136/fmch-2020-000845 The appetite for and ability to collect accurate digital patient-level data in low-resource settings has fueled numerous massive global health initiatives. A promising solution to produce meaningful data is the thoughtful and measured development and introduction of practical digital technology platforms.

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FDA Law Blog

AUGUST 4, 2022

Kirschenbaum — In a recent decision, the Second Circuit upheld the HHS Office of the Inspector General (OIG)’s position that Pfizer’s proposed copay assistance program for its high-cost heart treatment would violate the Federal Anti-Kickback Statute (AKS). Pfizer, Inc. Department of Health and Human Services et al. July 25, 2022. OIG disagreed.

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ABIM

JUNE 12, 2025

The questionnaire gathers information about clinical work and practice patterns, and ABIM uses the information to help update exam blueprints, develop policies for initial certification and MOC, and ensure adequately diverse representation of the profession in research. Community Practice in ABIM Governance* Erica N.

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FDA Law Blog

SEPTEMBER 26, 2024

What no one should find funny is how CDRH seems to be approaching Breakthrough devices of late, setting clinical study expectations so high that these innovative, novel, life-saving products may never get to the other side of the door, regardless of how much they knock. CDRH takes great pride in stating that it is committed to innovation.

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FDA Law Blog

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.

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FDA Law Blog

FEBRUARY 29, 2024

A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. That did not happen.

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FDA Law Blog

MAY 3, 2021

On April 28, FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov. The ClinicalTrials.gov database is a public database of clinical studies administered by the U.S. Cato & Michelle L. The notice was given to Acceleron Pharma, Inc., 42 U.S.C. §

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FDA Law Blog

AUGUST 23, 2022

The 80% sensitivity requirement for antigen tests has yet to be explained either scientifically or clinically by the Agency. While this was a step in the right direction, only the tests whose clinical studies occurred during the Omicron surge had this stipulation included in their labeling. That could happen again.

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FDA Law Blog

SEPTEMBER 18, 2024

However, there is a continuing disagreement between FDA and industry about how that phrase should be read with the phrase “and for which substantial clinical investigations have been institute and for which the existence of such investigations has been made public.”

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