FDA Law Blog

JUNE 23, 2021

I have witnessed it inform whether clinical trial results are clinically meaningful (or not) as well as the selection and even development of primary endpoints. What Dr. Cavazzoni lays out is the traditional way in which patients have informed drug benefit-risk decision-making: by setting the “clinical context” of the disease.

Patients 52

Patients Patient-Centered Clinic IT 52

FDA Law Blog

MARCH 17, 2022

We blogged on the final 2016 guideline here on March 17, 2016). Proposed 2022 CDC Clinical Practice Guideline for Prescribing Opioids, 87 Fed. et al, CDC Clinical Practice Guideline for Prescribing Opioids-United States, 2022, CDC. 2016 Guideline. CDC Clinical Practice Guideline, 10. 7,838 (Feb.

Patient-Centered 75

Patient-Centered Clinical Practice Patients Individual 75

Annals of Family Medicine

NOVEMBER 20, 2024

Population Studied – The Vizient® Clinical Data Base was queried for inpatient discharges between January 2016 and February 2024 with an ICD-10-CM diagnosis code for naegleriasis (B60.2). fowleri infections, reporting a broader age spectrum of affected individuals than traditionally reported.

Diagnosis 130

Diagnosis Patients Clinic Individual 130

The Clinical Problem Solvers

DECEMBER 20, 2021

Highlight how structural racism against Asian-Americans surfaces in clinical settings, and describe means of counteracting such structures. Creating spaces where these experiences can be shared by patients as well as by practitioners can highlight the structural nature of seemingly individualized problems.

Community 52

Community Patient-Centered Relationship Healthcare 52

FDA Law Blog

NOVEMBER 29, 2022

Houck — On November 4th, CDC issued its revised guideline on prescribing opioids for pain as an expansion and update of its 2016 CDC Opioid Prescribing Guideline. CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022. Expected clinical benefits should be weighed against risks before beginning therapy.

Patients 52

Patients Patient-Centered ER Individual 52

FDA Law Blog

MAY 5, 2024

Houck — The Associated Press reported on Tuesday following confirmation by five anonymous individuals with knowledge that the Drug Enforcement Administration (“DEA”) is moving to reschedule marijuana from schedule I to the less stringently controlled schedule III. By Larry K. 30, 2024). 53,688 (Aug. 53,767 (Aug.

Medical 95

Medical Manufacturing Physicals Healthcare Professional 95

GeriPal

MARCH 28, 2024

Ten years ago we would have been hard pressed to find 3 clinical trial abstracts submitted to the annual meeting, much less high quality randomized trials with robust measures, sample sizes, and analytics plans. Eric: And that’s similar to the 2016 JAMA paper, right? Did it negate everything from the 2016 trial?Palliative

Consulting 115

Consulting Patient-Centered IT Patients 115

The Clinical Problem Solvers

MAY 30, 2022

She urges us to recognize that maternal mortality changes the life trajectories of individuals and communities. Published April 20, 2016. The Clinical Problem Solvers Podcast – Antiracism in Medicine Series. Kozhimannil reminds us to look past the statistics and zoom into the personal level. Healthcare. 2020;8(1):100367.

Community 52

Community Patient-Centered Family Families 52

GeriPal

FEBRUARY 29, 2024

But when we have people in rural areas of California, so we don’t know our clinical site, we go from San Francisco all the way to the Northern California border, super rural areas. We’re willing to spend $50,000 a year for individuals for their expensive pharmacy medication. What would you do with the money, Eric?

IT 126

IT Patient-Centered Illness Education 126

BMJ

FEBRUARY 8, 2021

The proximity to campus health clinics may also afford college students greater accessibility to healthcare providers for prescription medications such as stimulants which could end up being misused. Besides the risks to an individual, there are also population-level harms from normalizing certain harmful behaviors (e.g., Pediatrics.

Medical 40

Medical Holistic Care Healthcare Healthcare Professional 40

GeriPal

APRIL 14, 2022

So I have thought about this for months, maybe years since your 2016, cycle blog, but we have picked Under Pressure by David Bowie and Queen. This is both a research and a clinical interest of yours. They don’t have an addiction clinic. Eric: And why Under Pressure. I’m going to start off with Katie. Right, Katie?

Illness 102

Illness Patient-Centered IT Patients 102

PEMBlog

MARCH 27, 2024

She is a member of the Clinical Genome Resource Inborn Errors of Metabolism (IEM) Clinical Domain Working Group, where as a biocurator she assesses the pathogenicity of variants in IEM-associated genes to facilitate expedited genetic diagnosis for IEMs. 2016 Jan;37(1):3-15; quiz 16-7, 47. Inborn Errors of Metabolism.

Consulting 59

Consulting Individual Family Families 59

GeriPal

APRIL 10, 2025

Why this study was a success due to the sheer size (nearly 100,000 patients in about 30 EDs) of the study, and the fact that, as far as the investigators know, all study sites continue to employ the clinical decision support tool. And then we had clinical decision support. What is a cluster stepped wedge randomized trial? Long overdue.

Patient-Centered 77

Patient-Centered IT Hospital Patients 77

GeriPal

DECEMBER 8, 2022

And then we also have another Vas, many of the interviews are done by medical students or other healthcare trainees as part of their clinical rotation at the VA. So like I said, I got to meet Thor, I believe it was May, 2016. Working with our clinical decision support team and thinking about where that could be. Heather: Yeah.

Patient-Centered 115

Patient-Centered Illness Healthcare IT 115

GeriPal

JUNE 30, 2022

Eric: So we’re going to be talking about dementia and considerations around surgery for individuals with dementia. So when I was a resident at Cleveland Clinic, I got to see really cutting-edge technology, some of the best surgeons in the country, and perhaps in the world, operating on patients. Samir: Thanks, Alex and Eric.

Patient-Centered 101

Patient-Centered Complication Patients IT 101

GeriPal

FEBRUARY 15, 2024

Wait, first of all, what’s the incidence of calling EMS for falls over almost a decade, I think like 2007 to 2016, and what happens to people afterwards? All of these are factors that are on the individual level. Eric: So you both published a paper in JAGS, what, 2018, ’19 looking at what happens to people? Eric: Yeah.

Community 115

Community Transportation IT PCP 115

GeriPal

APRIL 3, 2025

Annie 02:31 So if you go to the A G S meeting every year, you know that this group of three individuals comprises the AGS literature update. Annie 05:16 So if you look back in history, I think Eric and Ken have been doing this since 2016. But in spite of that, it is a lot of work for three individuals to pull all this together.

IT 64

IT Hospital Screening Patients 64

GeriPal

DECEMBER 15, 2022

And then we also have another Vas, many of the interviews are done by medical students or other healthcare trainees as part of their clinical rotation at the VA. So like I said, I got to meet Thor, I believe it was May, 2016. Working with our clinical decision support team and thinking about where that could be. Heather: Yeah.

IT 105

IT Patient-Centered Healthcare Illness 105

GeriPal

JANUARY 11, 2024

The number of people who have used MAID in Canada since it was legalized in 2016 has increased year on year from about 1,000 people in the first year to over 13,000 people in 2022. Alex: We’re delighted to welcome Leonie Herx, who’s a palliative care physician and clinical professor at the University of Calgary. Eric: Yeah.

Illness 144

Illness IT Medical Provider 144

GeriPal

AUGUST 24, 2023

Just an extraordinary cast of individuals who were really so incredibly inspiring. And then the final category, the third category is what we called the dignity conserving repertoire, which really has to do with kind of the spiritual, and psychological landscape and makeup of that individual. I mean, I was very much a clinician.

Patient-Centered 98

Patient-Centered Patients IT Illness 98

PEMBlog

DECEMBER 14, 2023

2016 Apr;83:78-83. But it might underestimate it because lots of mild cases don’t actually present clinically, and they’re not diagnosed endoscopically. Well, they could use lasers or cold steel or microdebridement, and it’s really tailored to the individual patient’s anatomy. And so how is that done?

Diagnosis 52

Diagnosis IT Diagnose Patients 52

GeriPal

JULY 28, 2022

And so often, these patients experience a lot of hospitalizations, numerous hospitalizations while they receive intensive chemotherapy that requires prolonged periods of neutropenia and toxicities, or stem cell transplantation, which is what I specialize in clinically now. Was in Journal of Clinical Oncology and that was interesting.

Illness 110

Illness Hospital Patient-Centered Patients 110

GeriPal

OCTOBER 5, 2023

We need to strike it from our vocabulary and leave sort of a gap in the clinical vernacular about how we talk about life-sustaining treatment. And I think one way that has really captured the imagination in critical care is the notion of a time-limited trial.

Illness 136

Illness IT Patient-Centered Family 136

GeriPal

AUGUST 25, 2022

And yet, we know little about the clinical experience of people with dementia in hospice. My interest in this paper and this topic goes back a long time and is based on my clinical experience as a hospice nurse, where I was taking care of what I felt like and what we’ve confirmed with research is about half of my patients.

Family 106

Family Families IT Patients 106

GeriPal

MARCH 30, 2023

As I was cleaning up my office, I found something I’d written in 2016. They’re limited because, on the individual level, when you get down to it, the complexities of these stories and the caring involved may lead to these complex relationships, understanding what the goals are, as you had done with your mom.

IT 96

IT Patient-Centered Patients Healthcare 96

BMJ

JUNE 25, 2021

1 Clinical guidelines internationally recommend statin therapy for both primary and secondary prevention of CVD, making statins one of the most frequently prescribed drugs in industrialised countries. In clinical practice, patients are not fixed on a certain treatment regime and can start and stop at any time.

Primary Care 40

Primary Care Clinical Practice Electronics Clinic 40

Alabama Academy of Family Physicians

FEBRUARY 20, 2025

Since 2016, HPAI H5N1 has been detected in wild birds in the United States during screening efforts by wildlife authorities. There have been a few severe cases and one individual died with H5N1 infection. H5N1 is currently known to be widespread among wild birds and is thought to be spread by migratory waterfowl.

Patient-Centered 130

Patient-Centered Provider Manufacturing Screening 130

GeriPal

JULY 25, 2024

Eric 04:39 Yeah, I see it used on inpatient, side on consult clinics in hospices. Eric 07:03 And those classic studies, were those done in the hospital and PALP care units and clinic? The folks that we were seeing either in clinic or inpatient, were probably a lot sicker than the ones that we’re seeing now.

Family 106

Family Families Patient-Centered Patients 106

GeriPal

APRIL 20, 2023

What are the structural factors and individual factors that contribute to homelessness? I would talk about this, except I was a clinician, and I’m seeing these folks in the hospital and in clinic. The journal section’s requirements are the same as for a clinical investigation. ” It was in my slide deck.

Mental Health 123

Mental Health IT Community Individual 123

GeriPal

DECEMBER 21, 2023

And that’s where, based on this, I made a decision to leave University of North Carolina to come to Indiana University because my mentor, Chris Callahan, just received the grant from AHRQ to build the first randomized clinical control trial that evaluated the comprehensive dementia care model. 2015, 2016. Malaz: Yeah.

Patient-Centered 125

Patient-Centered IT Family Families 125

FDA Law Blog

NOVEMBER 8, 2023

The rule established a new category of OTC hearing aids for individuals with mild to moderate hearing loss, allowing them to purchase hearing aids directly from stores or online retailers without the need for a medical examination, prescription, or fitting adjustment by an audiologist.

Utilities 64

Utilities IT Engineering Appointment 64

FDA Law Blog

SEPTEMBER 13, 2021

Currently, individual Medicare Part D plan sponsors negotiate rebates but the government is explicitly prohibited from interfering in those negotiations. According to HHS, Medicare Part D could have saved as much as $3 billion in 2016 if generics were substituted for brand-name drugs wherever they were available.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98