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NEJM This Week — December 28, 2023

NEJM This Week — December 28, 2023

Released Wednesday, 27th December 2023
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NEJM This Week — December 28, 2023

NEJM This Week — December 28, 2023

NEJM This Week — December 28, 2023

NEJM This Week — December 28, 2023

Wednesday, 27th December 2023
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2:00

for enrollment in 13.1% of the patients. 12.8%

2:05

of the patients were assigned to a treatment group

2:08

no more than 24 hours after stroke onset, and

2:10

87.2% were assigned after 24 hours and no more

2:12

than 72 hours after stroke onset. A

2:20

new stroke occurred in 7.3% of

2:22

patients in the clopidogrel aspirin group

2:24

and in 9.2% in the aspirin

2:26

group. Moderate

2:29

to severe bleeding occurred in 0.9%

2:33

of patients in the clopidogrel aspirin group and in

2:35

0.4% of those in the aspirin group. Among

2:40

patients with mild ischemic

2:42

stroke or high-risk TIA

2:44

of presumed atherosclerotic cause,

2:47

combined clopidogrel aspirin therapy

2:49

initiated within 72 hours

2:51

after stroke onset led to a

2:54

lower risk of new stroke at

2:56

90 days than aspirin therapy alone.

2:59

But was associated with a

3:01

low but higher risk of moderate to

3:03

severe bleeding. Anthony

3:05

Kim from the University of California

3:08

San Francisco writes in an editorial

3:10

that the trial by Gao and

3:13

colleagues provides evidence to support expanding

3:15

the time window for dual antiplatelet

3:17

therapy to 72 hours. This

3:21

timing should nevertheless be interpreted

3:23

as soon as possible

3:25

but within 72 hours and

3:28

still necessitates a loading dose

3:30

of clopidogrel since its omission

3:32

would be akin to delaying

3:34

treatment. The trial also

3:36

provides justification for the inclusion

3:38

of patients with slightly more

3:40

severe stroke symptoms than have

3:42

been evaluated in previous trials

3:44

up to an NIH-SS score

3:46

of five or less as

3:48

compared with the threshold of three or

3:51

less that had been used in some

3:53

trials. However, this expanded

3:55

inclusion criterion comes at the

3:57

cost of a small but

3:59

accruing. Bleeding risk that is

4:01

roughly proportional to the duration

4:03

of treatment. This. Bleeding

4:06

signal is a reminder that

4:08

the appropriate duration of duel

4:10

anti plate the therapy. To.

4:12

Balance early benefit. And.

4:15

Bleeding Risk. Seems to

4:17

be approximately twenty one days and

4:19

that long term use of Clopidogrel

4:22

aspirin is not recommended. Given that

4:24

this approach has not prove beneficial

4:26

and almost certainly increases bleeding risk.

4:29

The. Results of this trial also

4:31

cannot be generalized to patients with

4:34

heightened bleeding risks such as those

4:36

with a history of cerebral or

4:38

systemic hemorrhage, to those with severe

4:41

stroke or cardio and bollixed rope

4:43

not considered to be atherosclerotic in

4:45

origin, or to patients undergoing or

4:48

anticipated to undergo thrombolysis or thrown

4:50

back to me. In addition, there

4:53

is uncertain generalization to non Han

4:55

Chinese patience, given that Han Chinese

4:57

patience made up almost the entire.

5:00

Trial population. The. Incremental

5:02

expansion of indications for jewel anti

5:04

played The therapy said was shown

5:07

in this trial is welcome. Perhaps.

5:10

New, more targeted and thrombotic agents

5:12

on the horizon may hold promise

5:14

for delivering an even more favorable

5:17

balance of benefits and risks among

5:19

patients with stroke. Nurse

5:23

Seven Mab for prevention of

5:25

hospitalizations due to Rsv in

5:27

incense. By. Simon Drysdale

5:30

from St. George's University

5:32

of London. Respiratory.

5:35

Syncytial Virus Rsv is a

5:37

common seasonal cause of acute

5:39

lower respiratory tract infection in

5:42

young children and a leading

5:44

cause of hospitalization in infants.

5:46

This. study assessed the safety

5:48

of the monoclonal antibody nurse

5:51

seven mab and the effectiveness

5:53

seven map on hospitalizations for

5:55

rs be associated lower respiratory

5:57

tract infections when administered to

5:59

help 8,058

6:03

infants who were 12 months of age

6:05

or younger had been born at a

6:07

gestational age of at least 29 weeks

6:10

and were entering their first

6:12

RSV season in France, Germany

6:14

or the United Kingdom, were

6:16

randomly assigned to receive a

6:19

single intramuscular injection of nircevumab

6:21

or standard care, no intervention,

6:23

before or during the RSV

6:25

season. At

6:28

3% of the infants in

6:30

the nircevumab group and 1.5%

6:32

of those in the standard

6:35

care group were hospitalized for

6:37

RSV-associated lower respiratory tract infection,

6:39

which corresponded to a nircevumab

6:41

efficacy of 83.2%. Very

6:46

severe RSV-associated lower respiratory tract

6:48

infection occurred in 0.1% of

6:50

the infants in

6:52

the nircevumab group and in 0.5% of

6:55

those in the standard care group,

6:57

which represented a nircevumab efficacy of

6:59

75.7%. The

7:03

efficacy of nircevumab against hospitalization for

7:05

RSV-associated lower respiratory tract infection was

7:07

89.6% in France, 74.2% in Germany

7:09

and 83.4% in the United Kingdom.

7:18

Most related adverse events occurred in 2.1%

7:20

of infants in the nircevumab group. Nircevumab

7:26

protected infants against hospitalization

7:29

for RSV-associated lower respiratory

7:31

tract infection and against

7:34

very severe RSV-associated lower

7:36

respiratory tract infection in

7:39

conditions that approximated real-world

7:41

settings. In

7:44

an editorial, Natasha Halasa from

7:46

Vanderbilt University Medical Center, Nashville

7:48

writes that the findings in

7:50

the trial by Drysdale and

7:52

colleagues corresponded to a nircevumab

7:55

efficacy of 83.2%. Furthermore,

7:58

the efficacy of the NIRCEVUMAB group was only 1.2% in the NIRCEVUMAB group. and safety

8:00

outcomes observed in this trial,

8:02

which is being conducted in

8:04

conditions approximating real-world settings, are

8:06

consistent with findings from two

8:08

previous Phase III trials. For

8:11

more than 50 years, our

8:13

options to prevent RSV disease

8:15

have been largely ineffective or,

8:18

as with the previous and

8:20

current RSV prophylaxis products, have

8:23

been limited to selected high-risk

8:25

populations. The introduction of Nersevimab

8:28

brings a wave of excitement

8:30

because it offers a more

8:32

practical, single-dose alternative to previous

8:35

interventions and extends protection to

8:37

all infants. Maternal

8:40

vaccination is another recently introduced

8:42

option to prevent RSV infection

8:44

in infants. Therefore, finding a

8:46

good balance between the two strategies

8:48

will be necessary. Nersevimab

8:50

comes with new challenges alongside

8:53

its benefits. As high-income countries

8:55

begin to implement the administration

8:58

of Nersevimab, active surveillance for

9:00

RSV is critical in order

9:02

to evaluate the effectiveness of

9:05

Nersevimab and the evolution of

9:07

RSV. Equally important

9:10

are the five A's

9:12

of healthcare access, affordability,

9:15

availability, accessibility,

9:17

accommodation, and acceptability, especially

9:20

in low- and middle-income

9:22

countries where RSV-associated morbidity

9:24

and mortality are highest.

9:27

Ensuring that Nersevimab reaches these vulnerable

9:30

populations is not only a matter

9:32

of equity, but also imperative to

9:35

mitigate the global effects of RSV

9:37

on health and society. Far

9:42

Sentan versus Urbissartan

9:44

in Focal Segmental

9:46

Glamoryulosclerosis by Michel Rau

9:48

from the University of Minnesota

9:50

Medical School, Minneapolis. In

10:00

an eight-week phase two

10:02

trial, Sparsentan, a dual-endothelin

10:05

angiotensin receptor antagonist, reduced

10:08

proteinuria in patients with FSGS.

10:10

The current study evaluated the

10:13

efficacy and safety of longer-term

10:15

treatment with Sparsentan for FSGS.

10:19

371 patients with FSGS without known secondary

10:21

causes who were 8 to 75 years

10:24

of age were randomly

10:26

assigned to receive Sparsentan or Urbacartan,

10:29

the active control, for 108 weeks.

10:33

At 36 weeks, the percentage of

10:36

patients with partial remission of proteinuria

10:38

was 42 percent in the

10:40

Sparsentan group and 26 percent

10:42

in the Urbacartan group, a response that

10:44

was sustained through 108 weeks. At

10:48

the time of the final analysis at

10:50

week 108, there

10:53

were no significant between-group

10:55

differences in the estimated

10:57

glomerular filtration rate EGFR

10:59

slope. The between-group difference in

11:01

total slope, day 1 to week 108,

11:04

was 0.3 milliliters per minute

11:08

per 1.73 meters

11:10

squared of body surface area per

11:12

year. And the between-group difference in

11:14

the slope from week 6 to week 108,

11:17

that is, chronic slope, was 0.9 milliliters

11:19

per minute per 1.73 meters squared per

11:21

year. Sparsentan

11:26

and Urbacartan had similar safety profiles,

11:28

and the frequency of adverse events

11:30

was similar in the two groups.

11:33

Among patients with FSGS,

11:36

there were no significant

11:38

between-group differences in EGFR

11:40

slope at 108

11:43

weeks, despite a greater reduction

11:45

in proteinuria with Sparsentan than

11:47

with Urbacartan. treatment

12:00

with sparsentan to

12:02

decrease the decline in estimated

12:04

glomerular filtration rate, EGFR, as

12:07

compared with herbisartan in patients

12:09

with apparent primary FSGS. However,

12:13

sparsentan did decrease

12:15

proteinuria. Despite

12:17

the care with which the trial

12:19

was performed and regardless of the

12:22

use of the interim endpoint of

12:24

FSGS partial remission or other measures,

12:26

the investigators and we, the readers,

12:28

are left to grapple with why

12:31

the decreased proteinuria did not result

12:33

in amelioration of decline in kidney

12:35

function. The authors provide

12:37

multiple speculative reasons as to why

12:40

the results for the primary endpoint,

12:42

the EGFR slope, were not found

12:44

to be significant. Perhaps

12:47

two years is too little time

12:49

to see a difference in EGFR

12:51

decline in patients with FSGS. Other

12:54

possibilities raised included the heterogeneity

12:56

of the trial population. Most

12:59

of the patients in the trial

13:01

were white. A greater decrease in

13:03

EGFR at the time of treatment

13:05

initiation in the sparsentan group than

13:07

in the herbisartan group, which would

13:09

have meant stabilization or recovery was

13:12

needed, a better than

13:14

anticipated response in the herbisartan group,

13:16

the active control group, and

13:18

the relapsing nature of FSGS. However,

13:22

supportive data for such

13:24

speculation are incomplete. In

13:27

the end, does sparsentan offer

13:29

another arrow in the small

13:31

quiver of armaments with which

13:33

to treat FSGS? It

13:35

is a start, and one hopes

13:38

that further observation of the trial

13:40

participants in the ongoing open label

13:42

extension, plus additional studies aimed at

13:45

answering the many questions the trial

13:47

raises, will provide an answer. Laughter:

14:00

Robert Wood Johnson Medical School

14:02

New Brunswick, New Jersey. A

14:05

strategy of administering a transfusion

14:07

only when the hemoglobin level

14:09

falls below seven or eight

14:11

grams per deciliter has been

14:13

widely adopted. However, Patience

14:16

with acute myocardial infarction may

14:18

benefit from a higher hemoglobin

14:20

level. In. This Phase

14:22

three interventional trial three thousand,

14:24

five hundred for patients with

14:26

myocardial infarction and hemoglobin level

14:28

of less than ten grams

14:31

per deciliter were randomly assigned

14:33

to a restrictive transfusion strategy

14:35

hemoglobin cut off for transfusion

14:37

seven or eight grams per

14:39

deciliter or a liberal transfusion

14:41

strategy hemoglobin cut off less

14:44

than ten grams per deciliter.

14:46

The. Mean number of red cell

14:48

units that were transfused was zero

14:50

point seven in the restrictive strategy

14:53

group and two point five in

14:55

the Liberals strategy group. The.

14:57

Mean hemoglobin level was one point

14:59

three to one point six grams

15:02

per deciliter lower in the restrictive

15:04

strategy group than in the liberal

15:06

strategy group on days one to

15:08

three after randomization, A. Primary

15:10

outcome event of myocardial infarction or

15:13

death at thirty days occurred in

15:15

sixteen point nine percent of patients

15:17

in the Restrictive Strategy group, and

15:20

in fourteen point five percent of

15:22

patients in the Liberal Strategy group.

15:24

Death. Occurred in nine point nine

15:26

percent of the patients with the

15:29

restrictive strategy and in eight point

15:31

three percent of the patients with

15:33

the Liberals strategy. Myocardial.

15:35

Infarction occurred in eight point five

15:37

percent and seven point two percent

15:39

of the patients, respectively. In.

15:41

patients with acute myocardial

15:43

infarction and anemia a

15:45

liberal transfusion strategy did

15:47

not significantly reduce the

15:49

risk of recurrent myocardial

15:51

infarction were death at

15:53

thirty days however potential

15:55

harms of a restrictive

15:57

transfusion strategy can not

15:59

be excluded. In

16:02

an editorial, Evan Bloch and

16:04

Aaron Tobyan from Johns Hopkins

16:06

University School of Medicine, Baltimore,

16:08

write that red cell transfusion

16:11

is one of the most

16:13

commonly performed medical procedures. It

16:15

is also one of the

16:17

most overused medical procedures, which

16:19

largely neglects the associated risks,

16:21

costs, and sustainability of liberal

16:23

transfusion practices. In

16:25

1999, Ebert and

16:27

colleagues published their findings from

16:30

the landmark transfusion requirements in

16:32

critical care trial, results that

16:35

challenged the then standard practice

16:37

of liberal transfusion. The

16:40

trial showed that 30-day mortality

16:42

among critically ill patients was

16:44

not significantly different between those

16:46

who had been assigned to a

16:48

restrictive transfusion strategy and those who

16:51

had been assigned to a liberal

16:53

transfusion strategy. These findings

16:55

spurred numerous trials, which collectively

16:57

showed that a restrictive transfusion

17:00

strategy was safe and consistently

17:02

conferred clinical outcomes that were

17:04

similar or even superior to

17:06

those with a liberal strategy.

17:08

These trials transformed clinical practice

17:10

by offering moderate or high

17:13

quality evidence to support the

17:15

wide adoption of a hemoglobin

17:17

threshold of 7 to 8

17:19

grams per deciliter to trigger

17:21

transfusion. Now, Carson

17:24

and colleagues report the long-awaited

17:26

findings from their trial. Their

17:28

trial affords greater insight into

17:31

the complexity of clinical transfusion

17:33

practice. The findings underscore the

17:35

need to consider multiple factors

17:38

during evaluation of the patient,

17:40

such as transfusion indication, clinical

17:42

presentation, coexisting risk factors,

17:45

and degree of compensation when

17:47

deciding whether to administer transfusion

17:50

rather than rigidly adhere to a

17:53

hemoglobin threshold alone. The

17:55

trial also highlights the importance

17:57

of characterizing risk in individual

17:59

populations. rather than relying

18:01

on broad policy recommendations. Given

18:04

the risk-benefit calculation for transfusion,

18:06

at least in a high-income

18:08

setting, in which the risk

18:11

of transfusion-related adverse events is

18:13

low, the findings

18:15

from the trial by Carson and

18:17

colleagues favor a liberal transfusion strategy

18:20

for patients with acute myocardial

18:23

infarction. Wearable

18:26

Technology and Clinical Practice

18:28

for Depressive Disorder, a

18:30

review article by Shimon Firdor

18:33

from Massachusetts Institute of Technology,

18:35

Cambridge, and colleagues. Treatment

18:38

of depression is based on evaluation

18:40

for the presence and severity of

18:43

symptoms. Depression is

18:45

mostly diagnosed and monitored by

18:47

means of interview-based assessments or

18:49

self-report scales. Much of

18:52

this information is subjective and shaped

18:54

by the clinician's judgment. Hence,

18:56

it is prone to various biases that

18:59

may affect the quality of care. Self-report

19:02

scales have been used to

19:04

remotely monitor patient's symptoms between

19:07

clinical visits. If

19:09

these instruments are administered regularly,

19:11

they can reduce retrospective bias.

19:14

However, the burden on the

19:16

patient can limit how frequently

19:18

questionnaires are collected. Data

19:21

from wearable technology may serve

19:23

as a prompt to obtain

19:26

details of a patient's life

19:28

that might have otherwise been

19:30

missed. Traditional clinical assessments depend

19:32

on patient recall. Although such

19:34

recall can include important factors

19:36

that wearable technology, often termed

19:39

wearables, do not detect, such

19:41

as patients' reports of distress,

19:44

assessments by wearables of longitudinal

19:46

data from daily life may

19:48

augment methods of monitoring and

19:51

treating depression, providing objective

19:53

complements to subjective information

19:55

from patients. Wearables enable

19:57

passive monitoring, that is,

19:59

monitoring without active input

20:01

of behavioral and physiological

20:03

factors. The greater frequency

20:06

and objectivity of wearable

20:08

measurements help overcome some

20:10

of the limitations of

20:12

adherence and bias when

20:14

depression is monitored exclusively

20:16

with self-reports. Wearables support

20:18

personalized approaches to depression

20:21

treatment. Longitudinal measurements

20:23

help establish patient-specific behavioral

20:26

and physiological baselines and

20:28

support identification of

20:30

personalized factors that result in

20:33

deviations from these norms. A

20:36

clinician can use this ideographic,

20:38

within-person information, along

20:41

with more general, nomothetic, between-person

20:43

evidence from randomized controlled

20:46

trials to monitor condition changes

20:48

and adjust the treatment plan

20:51

for each patient. In

20:53

this review, the authors describe the state of the art

20:56

for using data from wearable

20:59

devices in diagnosing and managing

21:01

depression. A

21:04

70-year-old woman with cough and shortness of

21:06

breath, a case record of the Massachusetts

21:09

General Hospital by Rajesh

21:11

Gandhi and colleagues. A

21:14

70-year-old woman with advanced HIV

21:16

infection was evaluated in a

21:19

clinic in KwaZulu-Natal, South Africa,

21:21

because of cough, shortness of

21:23

breath, and malaise. Twelve

21:25

months earlier, the patient had new

21:28

shortness of breath, cough, anorexia, and

21:30

weight loss. During the

21:32

subsequent four weeks, the symptoms progressively

21:34

increased in severity. When the shortness

21:36

of breath worsened to the extent

21:38

that she was unable to walk,

21:40

she sought evaluation at the clinic.

21:43

Nucleic acid testing of a

21:45

nasopharyngeal swab was positive for

21:47

SARS-CoV-2. Subsequent testing

21:50

was positive for M tuberculosis.

21:52

During The ensuing six months,

21:54

the patient took antimicrobial medications

21:56

and the shortness of breath

21:58

and cough deeply. Creased, But.

22:01

Still persisted for months before the

22:03

current presentation, new headaches and mouth

22:05

ulcers developed. Her A R T

22:07

regimen was changed but the symptoms

22:09

did not a bait and the

22:12

patient presented to the clinic. For.

22:14

Additional evaluation. Given.

22:16

Her markedly immunocompromised state, her

22:18

physicians were concerned about the

22:20

possibility of persistent sars coby

22:23

to infection. Genomic data

22:25

from whole genome sequencing of

22:27

residual specimens strongly pointed toward

22:29

persistent sars cove the to

22:31

infection with in for a

22:33

host of Aleutian. Persistent.

22:36

Sars coby to infection would also

22:38

place this patient at risk for

22:40

a super infection. That might explain

22:42

the new onset of headaches. Super.

22:45

Infections that can occur after

22:47

coated nineteen include fungal infections

22:49

such as Aspergers, Los, or

22:52

Mew Core. My closest we

22:54

can lead to pneumonia or

22:56

rhino orbitals. cerebral disease, treatment

22:58

with intravenous Am for terrorists

23:01

and beat for suspected asper.

23:03

Josias was initiated. The.

23:06

I A R C Perspective

23:09

on alcohol reduction or cessation

23:11

and cancer risk. By.

23:13

Susan Gop stir from the

23:15

International Agency for Research on

23:17

Cancer. The all friends and

23:19

colleagues. Globally. Ethanol,

23:22

the principal form of alcohol

23:24

in alcoholic beverages, is the

23:27

most widely used psychoactive substance.

23:29

In. Two thousand and Nineteen forty

23:31

four percent of the global population,

23:34

fifteen years of age or older,

23:36

had consumed alcohol in the previous

23:38

year. The. Prevalence of alcohol

23:40

consumption varies considerably according to

23:43

geographic region, ranging from four

23:45

percent in the World Health

23:47

Organization Wh Oh Eastern Mediterranean

23:49

region, to at least sixty

23:51

percent in the European, American

23:53

and Western Pacific regions, and

23:55

is higher among men than

23:57

among women. The. international

23:59

age C for research on

24:01

cancer, IARC. Classified

24:04

alcoholic beverages as carcinogenic to

24:07

humans on the basis of

24:09

sufficient evidence of causality for

24:11

oral, pharyngeal, laryngeal,

24:14

esophageal, squamous cell,

24:16

liver, hepatocellular, colorectal

24:18

and breast cancers.

24:21

Ethanol in alcoholic beverages and

24:24

acid aldehyde that is associated

24:26

with consumption of alcoholic beverages

24:28

are also classified as carcinogenic

24:30

to humans. Worldwide, in 2020,

24:32

an estimated 741,300 new cancer cases, 4.1% of all new cancer cases, were

24:43

attributable to alcohol consumption. From

24:46

February through May, 2023, the

24:48

IARC Handbooks of Cancer Prevention

24:51

Program convened a working group

24:53

of 15 scientists, all

24:55

of whom are co-authors of

24:57

this article, from eight countries

24:59

to review published studies and

25:02

qualitatively evaluate the strength of

25:04

epidemiologic evidence on the potential

25:06

for alcohol reduction or cessation

25:08

to reduce alcohol-related cancer risk

25:10

and of mechanistic evidence on

25:12

the potential effects of alcohol

25:14

reduction or cessation to

25:16

reduce alcohol-related carcinogenesis. This

25:19

report presents a summary and

25:22

evaluation of the evidence. Community-based

25:27

doulas. Can clinicians share

25:29

power to improve maternal and

25:31

infant health outcomes? A perspective

25:33

by Dolly Presley Byrd from

25:35

the Mountain Area Health Education

25:37

Center, Asheville, North Carolina, and

25:40

colleagues. Black

25:42

birthing people in the United States

25:44

have higher rates of severe complications

25:47

than white birthing people. Black

25:49

birthing patients and infants are two to

25:51

three times as likely as their white

25:53

counterparts to die within a year after

25:56

delivery, even after adjustment

25:58

for education or socioeconomic factors.

26:01

Our current perinatal care model is

26:03

not working. We continue

26:05

to focus on standardization

26:07

and technology aimed at

26:09

enhancing safety while outcomes

26:11

worsen and racial inequities

26:14

increase. These authors believe

26:16

we must reconsider the status quo

26:18

and explore innovative solutions to this

26:20

dire problem. One approach

26:23

to addressing racial inequities in

26:25

perinatal outcomes is to encourage

26:27

partnerships between medical professionals, healthcare

26:30

organizations, and community-based doulas. During

26:32

the 18th and early 19th

26:34

centuries, most Black birthing people's

26:37

deliveries were attended by grand

26:39

midwives from their communities whose

26:42

lived experience was similar to

26:44

their own. With the

26:46

medicalization of childbirth and the

26:48

shifting of births from the

26:51

home to the hospital, the

26:53

medical establishment began emphasizing the

26:55

reduction of morbidity and mortality

26:57

while pushing birthing patients' preferences

26:59

and their chosen support systems

27:02

to the margins. Healthcare

27:04

teams that collaborate with

27:06

doulas rightfully recenter patients'

27:09

preferences for meaningful support

27:11

while ensuring patient safety

27:13

and agency. As

27:16

trained non-clinical professionals, doulas

27:18

provide physical, emotional, and

27:20

educational support during the

27:22

perinatal period while advocating

27:24

for patients. Research

27:26

shows that doula support reduces

27:29

C-section rates, NICU admissions,

27:31

and preterm births while increasing

27:34

breastfeeding rates and patient satisfaction.

27:37

Investment in collaborative relationships

27:39

could help dismantle a

27:42

rigid hierarchical healthcare system

27:44

that continually fails Black

27:46

birthing people. Data

27:50

sharing. A new era

27:52

for research funded by the U.S.

27:55

government. A perspective by Joseph Ross

27:57

from Yale School of Medicine, New

27:59

Haven, Connecticut. and colleagues. In

28:02

late January, 2023, the new

28:05

data management and sharing policy

28:08

of the National Institutes of

28:10

Health, which requires researchers to

28:12

share data that were generated

28:14

with NIH support, went

28:16

into effect. New proposals

28:19

and competitive renewals for research

28:21

grants must now include a

28:23

data management and sharing plan

28:26

that describes the data expected

28:28

to be generated, associated metadata,

28:31

timelines related to data

28:33

preservation and access, and

28:35

factors affecting distribution and

28:37

reuse, as well as

28:39

oversight arrangements and budgets

28:41

for allowable costs. This

28:44

policy, which was released in

28:46

October 2020, was developed after

28:48

many years of stakeholder engagement

28:50

with the goal of maximizing

28:52

the return on the public's

28:54

investment in research. The

28:56

Office of Science and Technology Policy,

28:59

an advisory group within the Executive

29:01

Office of the President, announced in

29:03

August 2022 that federal

29:06

agencies that fund research and

29:08

development activities must update their

29:10

public access policies to ensure

29:12

that all scientific data resulting

29:14

from federally funded research are, by

29:17

default, made freely and publicly

29:19

available at the time of

29:21

publication. The potential effects

29:23

of this shift in the clinical

29:25

research enterprise toward data sharing are

29:28

profound. There are clear opportunities

29:30

ahead, but there is a need for

29:32

a path forward to guide researchers. If

29:35

these efforts are successful, every

29:37

publicly funded project will have

29:39

two equally important goals. First,

29:42

to accomplish its research aims

29:44

of collecting and analyzing data

29:46

and reporting results to advance

29:48

science, and second, to produce

29:50

data that other investigators can

29:52

use to replicate findings and

29:55

produce new insights, thereby

29:57

accelerating and maximizing the

29:59

impact of U.S. government

30:01

funding of science. Poet

30:05

as Patient A perspective by

30:07

Richard Waring, a senior layout artist

30:09

at the journal. Richard

30:12

was diagnosed with atrial flutter and a rapid

30:14

heart rate of 150 beats per minute. Told

30:18

he was in heart failure, Richard suddenly

30:20

understood why he was having trouble breathing.

30:23

Three sleepless hospital nights, alone in

30:26

a dark room, he was offered

30:28

a short-term rescue. Two

30:30

hundred joules of electricity in the form of

30:32

a cardio version shocked his heart muscle back

30:34

to a rate of 100 beats

30:36

per minute. Over twelve days,

30:39

two teams of doctors at Beth

30:41

Israel Hospital in Boston debated whether

30:43

Richard could undergo a second open

30:45

heart surgery after a bicuspid aortic

30:48

valve repair in 2009, or

30:51

whether he was eligible for

30:53

a transcatheter aortic valve replacement,

30:55

TAVR, procedure that was less

30:57

risky, less invasive. Part

31:00

of endocarditis the previous summer added

31:02

another layer of complexity to the

31:04

decision making. Ultimately, Richard was

31:07

approved for the TAVR and sent home

31:09

to wait for a procedure date. While

31:12

in the hospital, Richard had managed to

31:14

write a series of poems that seemed

31:16

possible only in that setting, when

31:19

one was near death. He shared

31:21

his poems with the doctors to establish

31:23

a rapport. Then Richard received

31:25

a date for the TAVR procedure. The

31:28

procedure went smoothly, and Richard was not

31:30

among the two percent who they warned

31:33

could require emergency open heart

31:35

surgery or wind up dead.

31:38

Going into the surgical suite,

31:40

Richard was told he would

31:42

be receiving a sapien bovine

31:44

aortic valve, specially treated to

31:47

block calcium buildup and potentially

31:49

therefore last longer. He was

31:51

discharged from the hospital twenty-four

31:53

hours later. His

31:55

heart muscle, on the other hand, having

31:57

endured many ups and downs and partial

31:59

entropy. The can now rebuild the

32:01

strength over the next few months.

32:05

My. Heart and I have a

32:07

heart to heart. Everything will be

32:10

okay. In.

32:12

Our Images in Clinical Medicine A

32:15

twenty five year old woman with

32:17

severe obesity presented with a one

32:19

week history of blurred vision trends

32:22

and visual obscure Asians daily headaches

32:24

and intermittent pushing sounds. Neurologic.

32:26

Examination revealed optic disc swelling

32:29

in both eyes. M R

32:31

I showed flattened posteriori globes,

32:33

an empty seller and steno

32:35

sees as the transverse sinuses

32:38

without obstruction or thrombosis, all

32:40

of which were suggestive of

32:42

elevated cerebral spinal fluid pressure.

32:45

A. Lumbar puncture was notable for

32:47

an elevated opening pressure of

32:49

fifty five centimeters of water.

32:52

A diagnosis of idiopathic intracranial

32:54

hypertension was made. Idiopathic

32:56

intracranial hypertension is a

32:58

disorder associated with obesity

33:01

that manifests with symptoms

33:03

resulting from increased intracranial

33:05

pressure including headaches, diplo

33:07

be a visual field

33:09

defects, and pulses tile

33:11

tinnitus. Treatment. With High

33:14

Doses Seat Zola my with started and

33:16

counseling on weight loss was provided. In

33:20

another image, a seventy year old

33:22

man received a diagnosis of localized

33:24

sigmoid add know carcinoma after C

33:27

of the abdomen revealed Coli Dulko

33:29

with Diocese dilute hasten of the

33:31

common bile duct and know distant

33:34

metastasis. Plans had been made for

33:36

laparoscopic tumor resection cola suspect to

33:38

me and collects ya Skippy. During.

33:41

The Colin Jost could be Five

33:44

large flatworms were seen wriggling in

33:46

the Billie. I retract see the

33:48

video at any J M .org.

33:51

To. worms were extracted and identified

33:53

as cohen orcas sinensis a type

33:55

of liver flu season and says

33:57

is endemic in east asia Infection

34:00

occurs as a result of eating

34:02

raw or undercooked freshwater fish or

34:04

shrimp. After larvae are

34:06

ingested, they emerge from cysts in

34:08

the duodenum, ascend the biliary tree,

34:11

and mature into adult worms in

34:13

the biliary tract, gallbladder, or liver.

34:16

After the flatworms were removed, treatment

34:19

with PraziQuantel was administered,

34:21

and adjuvant chemotherapy for

34:23

sigmoid adenocarcinoma was initiated.

34:27

This concludes our summary. Let us

34:29

know what you think about our

34:31

podcast. Any comments or suggestions may

34:33

be sent to audio

34:36

at nejm.org. Thank

34:39

you for listening.

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