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Article ; Online: Organ Dysfunction in Sepsis: An Ominous Trajectory From Infection To Death.

Caraballo, César / Jaimes, Fabián

The Yale journal of biology and medicine

2019 Volume 92, Issue 4, Page(s) 629–640

Abstract: Sepsis is a highly complex and lethal syndrome with highly heterogeneous clinical manifestations that makes it difficult to detect and treat. It is also one of the major and most urgent global public health challenges. More than 30 million people are ... ...

Abstract	Sepsis is a highly complex and lethal syndrome with highly heterogeneous clinical manifestations that makes it difficult to detect and treat. It is also one of the major and most urgent global public health challenges. More than 30 million people are diagnosed with sepsis each year, with 5 million attributable deaths and long-term sequalae among survivors. The current international consensus defines sepsis as a life-threatening organ dysfunction caused by a dysregulated host response to an infection. Over the past decades substantial research has increased the understanding of its pathophysiology. The immune response induces a severe macro and microcirculatory dysfunction that leads to a profound global hypoperfusion, injuring multiple organs. Consequently, patients with sepsis might present dysfunction of virtually any system, regardless of the site of infection. The organs more frequently affected are kidneys, liver, lungs, heart, central nervous system, and hematologic system. This multiple organ failure is the hallmark of sepsis and determines patients' course from infection to recovery or death. There are tools to assess the severity of the disease that can also help to guide treatment, like the Sequential Organ Failure Assessment (SOFA) score. However, sepsis disease process is vastly heterogeneous, which could explain why interventions targeted to directly intervene its mechanisms have shown unsuccessful results and predicting outcomes with accuracy is still elusive. Thus, it is required to implement strong public health strategies and leverage novel technologies in research to improve outcomes and mitigate the burden of sepsis and septic shock worldwide.
MeSH term(s)	Cost of Illness ; Humans ; Microcirculation ; Multiple Organ Failure/blood ; Multiple Organ Failure/complications ; Multiple Organ Failure/mortality ; Oxygen ; Perfusion ; Sepsis/blood ; Sepsis/complications ; Sepsis/mortality
Chemical Substances	Oxygen (S88TT14065)
Language	English
Publishing date	2019-12-20
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	200515-3
ISSN	1551-4056 ; 0044-0086
ISSN (online)	1551-4056
ISSN	0044-0086
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Article ; Online: Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration's 510(k) Pathway and Risk of Subsequent Recalls.

Kadakia, Kushal T / Dhruva, Sanket S / Caraballo, César / Ross, Joseph S / Krumholz, Harlan M

JAMA

2023 Volume 329, Issue 2, Page(s) 136–143

Abstract: Importance: In the US, nearly all medical devices progress to market under the 510(k) pathway, which uses previously authorized devices (predicates) to support new authorizations. Current regulations permit manufacturers to use devices subject to a ... ...

Abstract	Importance: In the US, nearly all medical devices progress to market under the 510(k) pathway, which uses previously authorized devices (predicates) to support new authorizations. Current regulations permit manufacturers to use devices subject to a Class I recall-the FDA's most serious designation indicating a high probability of adverse health consequences or death-as predicates for new devices. The consequences for patient safety are not known. Objective: To determine the risk of a future Class I recall associated with using a recalled device as a predicate device in the 510(k) pathway. Design and setting: In this cross-sectional study, all 510(k) devices subject to Class I recalls from January 2017 through December 2021 (index devices) were identified from the FDA's annual recall listings. Information about predicate devices was extracted from the Devices@FDA database. Devices authorized using index devices as predicates (descendants) were identified using a regulatory intelligence platform. A matched cohort of predicates was constructed to assess the future recall risk from using a predicate device with a Class I recall. Main outcomes and measures: Devices were characterized by their regulatory history and recall history. Risk ratios (RRs) were calculated to compare the risk of future Class I recalls between devices descended from predicates with matched controls. Results: Of 156 index devices subject to Class I recall from 2017 through 2021, 44 (28.2%) had prior Class I recalls. Predicates were identified for 127 index devices, with 56 (44.1%) using predicates with a Class I recall. One hundred four index devices were also used as predicates to support the authorization of 265 descendant devices, with 50 index devices (48.1%) authorizing a descendant with a Class I recall. Compared with matched controls, devices authorized using predicates with Class I recalls had a higher risk of subsequent Class I recall (6.40 [95% CI, 3.59-11.40]; P<.001). Conclusions and relevance: Many 510(k) devices subjected to Class I recalls in the US use predicates with a known history of Class I recalls. These devices have substantially higher risk of a subsequent Class I recall. Safeguards for the 510(k) pathway are needed to prevent problematic predicate selection and ensure patient safety.
MeSH term(s)	Humans ; Cross-Sectional Studies ; Databases, Factual ; Device Approval/legislation & jurisprudence ; Device Approval/standards ; Medical Device Recalls/legislation & jurisprudence ; Medical Device Recalls/standards ; United States ; United States Food and Drug Administration/legislation & jurisprudence
Language	English
Publishing date	2023-01-10
Publishing country	United States
Document type	Journal Article
ZDB-ID	2958-0
ISSN	1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
ISSN (online)	1538-3598
ISSN	0254-9077 ; 0002-9955 ; 0098-7484
DOI	10.1001/jama.2022.23279
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Article ; Online: Timing of Blood Draws Among Patients Hospitalized in a Large Academic Medical Center.

Caraballo, César / Mahajan, Shiwani / Murugiah, Karthik / Mortazavi, Bobak J / Lu, Yuan / Khera, Rohan / Krumholz, Harlan M

JAMA

2023 Volume 329, Issue 3, Page(s) 255–257

MeSH term(s)	Humans ; Academic Medical Centers ; Hospitalization ; Time Factors ; Phlebotomy
Language	English
Publishing date	2023-01-16
Publishing country	United States
Document type	Journal Article
ZDB-ID	2958-0
ISSN	1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
ISSN (online)	1538-3598
ISSN	0254-9077 ; 0002-9955 ; 0098-7484
DOI	10.1001/jama.2022.21509
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Article ; Online: Patterns of Digoxin Prescribing for Medicare Beneficiaries in the United States 2013-2019.

See, Claudia / Wheelock, Kevin M / Caraballo, César / Khera, Rohan / Annapureddy, Amarnath / Mahajan, Shiwani / Lu, Yuan / Krumholz, Harlan M / Murugiah, Karthik

American journal of medicine open

2023 Volume 10

Abstract: Background: Studies show that digoxin use is declining but is still prevalent. Recent data on digoxin prescription and characteristics of digoxin prescribers are unknown, which can help understand its contemporary use.: Methods: Using Medicare Part D ...

Abstract	Background: Studies show that digoxin use is declining but is still prevalent. Recent data on digoxin prescription and characteristics of digoxin prescribers are unknown, which can help understand its contemporary use. Methods: Using Medicare Part D data from 2013 to 2019, we studied the change in number and proportion of digoxin prescriptions and digoxin prescribers, overall and by specialty. Using logistic regression, we identified prescriber characteristics associated with digoxin prescription. Results: From 2013 to 2019, total digoxin prescriptions (4.6 to 1.8 million) and proportion of digoxin prescribers decreased (9.1% to 4.3% overall; 26.6% to 11.8% among General Medicine prescribers and 65.4% to 48.9% among Cardiology). Of digoxin prescribers from 2013 practicing in 2019 (91.2% remained active), 59.1% did not prescribe digoxin at all, 31.7% reduced, and 9.2% maintained or increased prescriptions. The proportion of all digoxin prescriptions that were prescribed by General Medicine prescribers declined from 59.7% to 48.2% and increased for Cardiology (29% to 38.5%). Among new prescribers in 2019 ( Conclusions: Digoxin prescriptions continue to decline with over half of 2013 prescribers no longer prescribing digoxin in 2019. This may be a result of the increasing availability of newer heart failure therapies. The decline in digoxin prescription was greater among general medicine physicians than cardiologists, suggesting a change in digoxin use to a medication prescribed increasingly by specialists.
Language	English
Publishing date	2023-06-24
Publishing country	United States
Document type	Journal Article
ISSN	2667-0364
ISSN (online)	2667-0364
DOI	10.1016/j.ajmo.2023.100048
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Article ; Online: Developing an Actionable Taxonomy of Persistent Hypertension Using Electronic Health Records.

Lu, Yuan / Xinxin Du, Cindy / Khidir, Hazar / Caraballo, César / Mahajan, Shiwani / Spatz, Erica S / Curry, Leslie A / Krumholz, Harlan M

Circulation. Cardiovascular quality and outcomes

2023 Volume 16, Issue 3, Page(s) e009453

Abstract: Background: The digital transformation of medical data presents opportunities for novel approaches to manage patients with persistent hypertension. We sought to develop an actionable taxonomy of patients with persistent hypertension (defined as 5 or ... ...

Abstract	Background: The digital transformation of medical data presents opportunities for novel approaches to manage patients with persistent hypertension. We sought to develop an actionable taxonomy of patients with persistent hypertension (defined as 5 or more consecutive measurements of blood pressure ≥160/100 mmHg over time) based on data from the electronic health records. Methods: This qualitative study was a content analysis of clinician notes in the electronic health records of patients in the Yale New Haven Health System. Eligible patients were 18 to 85 years and had blood pressure ≥160/100 mmHg at 5 or more consecutive outpatient visits between January 1, 2013 and October 31, 2018. A total of 1664 patients met criteria, of which 200 records were randomly selected for chart review. Through a systematic, inductive approach, we developed a rubric to abstract data from the electronic health records and then analyzed the abstracted data qualitatively using conventional content analysis until saturation was reached. Results: We reached saturation with 115 patients, who had a mean age of 66.0 (SD, 11.6) years; 54.8% were female; 52.2%, 30.4%, and 13.9% were White, Black, and Hispanic patients. We identified 3 content domains related to persistence of hypertension: (1) non-intensification of pharmacological treatment, defined as absence of antihypertensive treatment intensification in response to persistent severely elevated blood pressure; (2) non-implementation of prescribed treatment, defined as a documentation of provider recommending a specified treatment plan to address hypertension but treatment plan not being implemented; and (3) non-response to prescribed treatment, defined as clinician-acknowledged persistent hypertension despite documented effort to escalate existing pharmacologic agents and addition of additional pharmacologic agents with presumption of adherence. Conclusions: This study presents a novel actionable taxonomy for classifying patients with persistent hypertension by their contributing causes based on electronic health record data. These categories can be automated and linked to specific types of actions to address them.
MeSH term(s)	Aged ; Female ; Humans ; Male ; Antihypertensive Agents/therapeutic use ; Blood Pressure ; Electronic Health Records ; Hypertension/diagnosis ; Hypertension/drug therapy ; Hypertension/epidemiology ; Middle Aged
Chemical Substances	Antihypertensive Agents
Language	English
Publishing date	2023-02-02
Publishing country	United States
Document type	Journal Article
ZDB-ID	2483197-9
ISSN	1941-7705 ; 1941-7713
ISSN (online)	1941-7705
ISSN	1941-7713
DOI	10.1161/CIRCOUTCOMES.122.009453
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Article ; Online: Association of marital/partner status with hospital readmission among young adults with acute myocardial infarction.

Zhu, Cenjing / Dreyer, Rachel P / Li, Fan / Spatz, Erica S / Caraballo, César / Mahajan, Shiwani / Raparelli, Valeria / Leifheit, Erica C / Lu, Yuan / Krumholz, Harlan M / Spertus, John A / D'Onofrio, Gail / Pilote, Louise / Lichtman, Judith H

PloS one

2024 Volume 19, Issue 1, Page(s) e0287949

Abstract: Introduction: Despite evidence supporting the benefits of marriage on cardiovascular health, the impact of marital/partner status on the long-term readmission of young acute myocardial infarction (AMI) survivors is less clear. We examined the ... ...

Abstract	Introduction: Despite evidence supporting the benefits of marriage on cardiovascular health, the impact of marital/partner status on the long-term readmission of young acute myocardial infarction (AMI) survivors is less clear. We examined the association between marital/partner status and 1-year all-cause readmission and explored sex differences among young AMI survivors. Methods: Data were from the VIRGO study (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients), which enrolled young adults aged 18-55 years with AMI (2008-2012). The primary end point was all-cause readmission within 1 year of hospital discharge, obtained from medical records and patient interviews and adjudicated by a physician panel. We performed Cox proportional hazards models with sequential adjustment for demographic, socioeconomic, clinical, and psychosocial factors. Sex-marital/partner status interaction was also tested. Results: Of the 2,979 adults with AMI (2002 women [67.2%]; mean age 48 [interquartile range, 44-52] years), unpartnered individuals were more likely to experience all-cause readmissions compared with married/partnered individuals within the first year after hospital discharge (34.6% versus 27.2%, hazard ratio [HR] = 1.31; 95% confidence interval [CI], 1.15-1.49). The association attenuated but remained significant after adjustment for demographic and socioeconomic factors (adjusted HR, 1.16; 95% CI, 1.01-1.34), and it was not significant after further adjusting for clinical factors and psychosocial factors (adjusted HR, 1.10; 95%CI, 0.94-1.28). A sex-marital/partner status interaction was not significant (p = 0.69). Sensitivity analysis using data with multiple imputation and restricting outcomes to cardiac readmission yielded comparable results. Conclusions: In a cohort of young adults aged 18-55 years, unpartnered status was associated with 1.3-fold increased risk of all-cause readmission within 1 year of AMI discharge. Further adjustment for demographic, socioeconomic, clinical, and psychosocial factors attenuated the association, suggesting that these factors may explain disparities in readmission between married/partnered versus unpartnered young adults. Whereas young women experienced more readmission compared to similar-aged men, the association between marital/partner status and 1-year readmission did not vary by sex.
MeSH term(s)	Humans ; Male ; Female ; Young Adult ; Middle Aged ; Patient Readmission ; Risk Factors ; Myocardial Infarction/epidemiology ; Socioeconomic Factors ; Heart
Language	English
Publishing date	2024-01-26
Publishing country	United States
Document type	Journal Article
ZDB-ID	2267670-3
ISSN	1932-6203 ; 1932-6203
ISSN (online)	1932-6203
ISSN	1932-6203
DOI	10.1371/journal.pone.0287949
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Article ; Online: Post Hospital Syndrome: Is the Stress of Hospitalization Causing Harm?

Caraballo, César / Dharmarajan, Kumar / Krumholz, Harlan M

Revista espanola de cardiologia (English ed.)

2019 Volume 72, Issue 11, Page(s) 896–898

MeSH term(s)	Delivery of Health Care/standards ; Hospitalization ; Humans ; Risk Factors ; Stress, Psychological/etiology ; Syndrome
Language	Spanish
Publishing date	2019-06-04
Publishing country	Spain
Document type	Editorial
ISSN	1885-5857
ISSN (online)	1885-5857
DOI	10.1016/j.rec.2019.04.010
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Article ; Online: Trends in Racial and Ethnic Disparities in Barriers to Timely Medical Care Among Adults in the US, 1999 to 2018.

Caraballo, César / Ndumele, Chima D / Roy, Brita / Lu, Yuan / Riley, Carley / Herrin, Jeph / Krumholz, Harlan M

JAMA health forum

2022 Volume 3, Issue 10, Page(s) e223856

Abstract: Importance: Racial and ethnic disparities in delayed medical care for reasons that are not directly associated with the cost of care remain understudied.: Objective: To describe trends in racial and ethnic disparities in barriers to timely medical ... ...

Abstract	Importance: Racial and ethnic disparities in delayed medical care for reasons that are not directly associated with the cost of care remain understudied. Objective: To describe trends in racial and ethnic disparities in barriers to timely medical care among adults during a recent 20-year period. Design, setting, and participants: This was a serial cross-sectional study of 590 603 noninstitutionalized adults in the US using data from the National Health Interview Survey from 1999 to 2018. Data analyses were performed from December 2021 through August 2022. Exposures: Self-reported race, ethnicity, household income, and sex. Main outcomes and measures: Temporal trends in disparities regarding 5 specific barriers to timely medical care: inability to get through by telephone, no appointment available soon enough, long waiting times, inconvenient office or clinic hours, and lack of transportation. Results: The study cohort comprised 590 603 adult respondents (mean [SE] age, 46.00 [0.07] years; 329 638 [51.9%] female; 27 447 [4.7%] Asian, 83 929 [11.8%] Black, 98 692 [13.8%] Hispanic/Latino, and 380 535 [69.7%] White). In 1999, the proportion of each race and ethnicity group reporting any of the 5 barriers to timely medical care was 7.3% among the Asian group; 6.9%, Black; 7.9%, Hispanic/Latino; and 7.0%, White (P > .05 for each difference compared with White individuals). From 1999 to 2018, this proportion increased across all 4 race and ethnicity groups (by 5.7, 8.0, 8.1, and 5.9 percentage points [pp] among Asian, Black, Hispanic/Latino, and White individuals, respectively; P < .001 for each), slightly increasing the disparities between groups. In 2018, compared with White individuals, the proportion reporting any barrier was 2.1 and 3.1 pp higher among Black and Hispanic/Latino individuals (P = .03 and P = .001, respectively). There was no significant difference in prevalence between Asian and White individuals. There was a significant increase in the difference in prevalence between Black individuals and White individuals who reported delaying care because of long waiting times at the clinic or medical office and because of a lack of transportation (1.5 pp and 1.8 pp; P = .03 and P = .01, respectively). In addition, the difference in prevalence between Hispanic/Latino and White individuals who reported delaying care because of long waiting times increased significantly (2.6 pp; P < .001). Conclusions and relevance: The findings of this serial cross-sectional study of data from the National Health Interview Survey suggest that barriers to timely medical care in the US increased for all population groups from 1999 to 2018, with associated increases in disparities among race and ethnicity groups. Interventions beyond those currently implemented are needed to improve access to medical care and to eliminate disparities among race and ethnicity groups.
MeSH term(s)	Adult ; Female ; Humans ; Middle Aged ; Male ; Ethnicity ; Hispanic or Latino ; Cross-Sectional Studies ; Black People ; Cohort Studies
Language	English
Publishing date	2022-10-07
Publishing country	United States
Document type	Journal Article
ISSN	2689-0186
ISSN (online)	2689-0186
DOI	10.1001/jamahealthforum.2022.3856
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Article ; Online: Temporal Trends in Racial and Ethnic Disparities in Multimorbidity Prevalence in the United States, 1999-2018.

Caraballo, César / Herrin, Jeph / Mahajan, Shiwani / Massey, Daisy / Lu, Yuan / Ndumele, Chima D / Drye, Elizabeth E / Krumholz, Harlan M

The American journal of medicine

2022 Volume 135, Issue 9, Page(s) 1083–1092.e14

Abstract: Background: Disparities in multimorbidity prevalence indicate health inequalities, as the risk of morbidity does not intrinsically differ by race/ethnicity. This study aimed to determine if multimorbidity differences by race/ethnicity are decreasing ... ...

Abstract	Background: Disparities in multimorbidity prevalence indicate health inequalities, as the risk of morbidity does not intrinsically differ by race/ethnicity. This study aimed to determine if multimorbidity differences by race/ethnicity are decreasing over time. Methods: Serial cross-sectional analysis of the National Health Interview Survey, 1999-2018. Included individuals were ≥18 years old and categorized by self-reported race, ethnicity, age, and income. The main outcomes were temporal trends in multimorbidity prevalence based on the self-reported presence of ≥2 of 9 common chronic conditions. Findings: The study sample included 596,355 individuals (4.7% Asian, 11.8% Black, 13.8% Latino/Hispanic, and 69.7% White). In 1999, the estimated prevalence of multimorbidity was 5.9% among Asian, 17.4% among Black, 10.7% among Latino/Hispanic, and 13.5% among White individuals. Prevalence increased for all racial/ethnic groups during the study period (P ≤ .001 for each), with no significant change in the differences between them. In 2018, compared with White individuals, multimorbidity was more prevalent among Black individuals (+2.5 percentage points) and less prevalent among Asian and Latino/Hispanic individuals (-6.6 and -2.1 percentage points, respectively). Among those aged ≥30 years, Black individuals had multimorbidity prevalence equivalent to that of Latino/Hispanic and White individuals aged 5 years older, and Asian individuals aged 10 years older. Conclusions: From 1999 to 2018, a period of increasing multimorbidity prevalence for all the groups studied, there was no significant progress in eliminating disparities between Black individuals and White individuals. Public health interventions that prevent the onset of chronic conditions in early life may be needed to eliminate these disparities.
MeSH term(s)	Adolescent ; Adult ; Chronic Disease ; Cross-Sectional Studies ; Ethnicity ; Humans ; Multimorbidity ; Prevalence ; United States/epidemiology
Language	English
Publishing date	2022-04-25
Publishing country	United States
Document type	Journal Article
ZDB-ID	80015-6
ISSN	1555-7162 ; 1873-2178 ; 0002-9343 ; 1548-2766
ISSN (online)	1555-7162 ; 1873-2178
ISSN	0002-9343 ; 1548-2766
DOI	10.1016/j.amjmed.2022.04.010
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Article ; Online: Cardiac Status Among Heart Failure Patients With Implantable Cardioverter Defibrillators Before, During, and After COVID-19 Lockdown.

Lu, Yuan / Jones, Paul W / Caraballo, César / Mahajan, Shiwani / Massey, Daisy S / Ahmed, Rezwan / Bader, Eric M / Krumholz, Harlan M

Journal of cardiac failure

2022 Volume 28, Issue 8, Page(s) 1372–1374

MeSH term(s)	COVID-19 ; Communicable Disease Control ; Death, Sudden, Cardiac ; Defibrillators, Implantable ; Electric Countershock ; Heart Failure/epidemiology ; Heart Failure/therapy ; Humans
Language	English
Publishing date	2022-06-08
Publishing country	United States
Document type	Letter ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	1281194-4
ISSN	1532-8414 ; 1071-9164
ISSN (online)	1532-8414
ISSN	1071-9164
DOI	10.1016/j.cardfail.2022.05.012
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