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1.
Nat Ment Health ; 2(7): 865-876, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-39005547

RESUMO

Cannabis, one of the most widely used psychoactive substances worldwide, can give rise to acute cannabis-associated psychotic symptoms (CAPS). While distinct study designs have been used to examine CAPS, an overarching synthesis of the existing findings has not yet been carried forward. To that end, we quantitatively pooled the evidence on rates and predictors of CAPS (k = 162 studies, n = 210,283 cannabis-exposed individuals) as studied in (1) observational research, (2) experimental tetrahydrocannabinol (THC) studies, and (3) medicinal cannabis research. We found that rates of CAPS varied substantially across the study designs, given the high rates reported by observational and experimental research (19% and 21%, respectively) but not medicinal cannabis studies (2%). CAPS was predicted by THC administration (for example, single dose, Cohen's d = 0.7), mental health liabilities (for example, bipolar disorder, d = 0.8), dopamine activity (d = 0.4), younger age (d = -0.2), and female gender (d = -0.09). Neither candidate genes (for example, COMT, AKT1) nor other demographic variables (for example, education) predicted CAPS in meta-analytical models. The results reinforce the need to more closely monitor adverse cannabis-related outcomes in vulnerable individuals as these individuals may benefit most from harm-reduction efforts.

2.
JPEN J Parenter Enteral Nutr ; 48(5): 562-570, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38949827

RESUMO

BACKGROUND: Patients with inflammatory bowel disease (IBD) are at increased risk of thrombosis. They often need parenteral nutrition (PN) requiring intravenous access for prolonged periods. We assessed the risk of deep vein thrombosis (DVT) associated with peripherally inserted central catheters (PICCs) and tunneled catheters for patients with IBD receiving home PN (HPN). METHODS: Using the Cleveland Clinic HPN Registry, we retrospectively studied a cohort of adults with IBD who received HPN between June 30, 2019 and January 1, 2023. We collected demographics, catheter type, and catheter-associated DVT (CADVT) data. We performed descriptive statistics and Poisson tests to compare CADVT rates among parameters of interest. We generated Kaplan-Meier graphs to illustrate longevity of CADVT-free survival and a Cox proportional hazard model to calculate the hazard ratio associated with CADVT. RESULTS: We collected data on 407 patients, of which, 276 (68%) received tunneled catheters and 131 (32%) received PICCs as their initial catheter. There were 17 CADVTs with an overall rate of 0.08 per 1000 catheter days, whereas individual rates of DVT for PICCs and tunneled catheters were 0.16 and 0.05 per 1000 catheter days, respectively (P = 0.03). After adjusting for age, sex, and comorbidity, CADVT risk was significantly higher for PICCs compared with tunneled catheters, with an adjusted hazard ratio of 2.962 (95% CI=1.140-7.698; P = 0.025) and adjusted incidence rate ratio of 3.66 (95% CI=2.637-4.696; P = 0.013). CONCLUSION: Our study shows that CADVT risk is nearly three times higher with PICCs compared with tunneled catheters. We recommend tunneled catheter placement for patients with IBD who require HPN infusion greater than 30 days.


Assuntos
Cateterismo Venoso Central , Doenças Inflamatórias Intestinais , Nutrição Parenteral no Domicílio , Trombose Venosa , Humanos , Estudos Retrospectivos , Masculino , Feminino , Trombose Venosa/etiologia , Trombose Venosa/epidemiologia , Doenças Inflamatórias Intestinais/complicações , Adulto , Nutrição Parenteral no Domicílio/efeitos adversos , Nutrição Parenteral no Domicílio/métodos , Pessoa de Meia-Idade , Cateterismo Venoso Central/efeitos adversos , Cateterismo Venoso Central/métodos , Fatores de Risco , Cateterismo Periférico/efeitos adversos , Cateteres Venosos Centrais/efeitos adversos , Modelos de Riscos Proporcionais , Estudos de Coortes , Sistema de Registros , Idoso
3.
Artigo em Inglês | MEDLINE | ID: mdl-38973817

RESUMO

Background: The positive predictive value (PPV) of the International Classification of Diseases, Ninth Revision-Clinical Modification (ICD-9-CM) code for "essential and other specified forms of tremor" in identifying essential tremor (ET) cases was found to be less than 50%. The ability of the ICD-10-CM G25.0 code for "essential tremor" to identify ET has not been determined. The study objective was to determine the PPV of the G25.0 code. Methods: Patients in a tertiary health system with a primary care encounter associated with ICD-10-CM code G25.0 in 2022 underwent medical record review to determine if the consensus criteria from the International Parkinson and Movement Disorder Society for an ET diagnosis were met. Results: 442 patients were included. The PPV of G25.0 in identifying probable ET cases was 74.7% (95% confidence interval (CI) 70.4-78.5%). Among patients prescribed propranolol, the PPV improved to 87.8% (95% CI 78.0-93.6%). Discussion: Compared to the ICD-9-CM code 333.1, G25.0 is superior for identifying ET cases. A potential limitation of this study is that the consensus criteria applied relies on nonspecific physical exam findings which may lead to an overestimation of the PPV of G25.0. Highlights: The ICD-10-CM diagnosis code for essential tremor has not been previously validated. The objective of this study was to determine the PPV of the G25.0 code. The PPV in identifying essential tremor cases was 74.7%. The PPV improved among patients prescribed propranolol.


Assuntos
Tremor Essencial , Classificação Internacional de Doenças , Humanos , Tremor Essencial/diagnóstico , Tremor Essencial/classificação , Classificação Internacional de Doenças/normas , Feminino , Masculino , Idoso , Pessoa de Meia-Idade , Idoso de 80 Anos ou mais , Propranolol/uso terapêutico
4.
Clin Genitourin Cancer ; 22(4): 102104, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-38834500

RESUMO

BACKGROUND: Immune checkpoint inhibitors (ICI) have significantly improved survival outcomes of metastatic renal cell carcinoma (mRCC). However, ethnic and racial minorities are often underrepresented in ICI clinical trials, leading to limited knowledge about ICI-specific survival outcomes for mRCC across different racial and ethnic groups. We investigated the impact of race and ethnicity on the ICI-specific survival outcomes of mRCC. MATERIALS: We used The National Cancer Database (NCDB) to retrieve the data of 4858 mRCC patients diagnosed from 2014 to 2019 and receiving ICI-based regimens. We then compared survival outcomes using the Kaplan-Meier method and the Log-rank test. We analyzed the data using univariate and multivariable Cox regression analysis, adjusted for age, sex, comorbidity index, treatment centers, and grade. RESULTS: White and Asian patients had significantly longer median overall survival (mOS) than African American (AA) patients (23.2 [95% CI 21.6, 24.7; P = .001] and 22.2 [95% CI 16.4, 55.1; P = .047] vs. 14.8 [95% CI 11.9, 19.2] months, respectively). After adjustment, White patients had significantly longer median OS (adjusted hazard ratio [HR] 0.71 [95% CI 0.58, 0.84]; P = .001). There was no significant difference in the mOS between Hispanic and non-Hispanic patients (P = .39). CONCLUSION: Black race is an independent predictor of ICI-related survival in mRCC patients, independent of sociodemographics, clinicopathological, and treatment-related factors. Future research is required to understand the underlying reasons for these disparities, including potential genetic or biological differences and social and environmental factors.


Assuntos
Carcinoma de Células Renais , Disparidades em Assistência à Saúde , Inibidores de Checkpoint Imunológico , Neoplasias Renais , Humanos , Carcinoma de Células Renais/tratamento farmacológico , Carcinoma de Células Renais/mortalidade , Masculino , Feminino , Neoplasias Renais/tratamento farmacológico , Neoplasias Renais/mortalidade , Neoplasias Renais/patologia , Pessoa de Meia-Idade , Idoso , Disparidades em Assistência à Saúde/estatística & dados numéricos , Inibidores de Checkpoint Imunológico/uso terapêutico , Imunoterapia , Estados Unidos/epidemiologia , Negro ou Afro-Americano/estatística & dados numéricos , Estudos Retrospectivos , Minorias Étnicas e Raciais/estatística & dados numéricos , População Branca/estatística & dados numéricos , Taxa de Sobrevida
5.
JACC Adv ; 3(4): 100895, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38939674

RESUMO

Background: Pediatric pulmonary embolism (PE) is rare and potentially life-threatening. Though thrombolysis and thrombectomy are increasingly used in adult PE, trends in pediatric treatment and outcomes remain incompletely described. Objectives: The purpose of this study was to describe the incidence of PE, proportion of cases treated with anticoagulation alone, systemic thrombolysis, and directed therapy (local thrombolysis and thrombectomy), clinical outcomes, and total costs. Methods: A multicenter observational study was performed using administrative data from the Pediatric Health Information System database to study PE treated at U.S. pediatric hospitals from 2015 to 2021. Outcomes by treatment were evaluated using multivariable generalized linear mixed effects models. Results: Of 3,136 subjects, 70% were at least 12 years of age, and 46% were male. Sixty-two percent had at least 1 comorbidity, and congenital heart disease of any kind was the most prevalent (20%). Eighty-eight percent of subjects received anticoagulation alone, 7% received systemic thrombolysis, and 5% received directed therapy. Overall in-hospital mortality was 7.5%. Treatment approach did not change over time (P = 0.98). After adjusting for patient characteristics, directed therapy was associated with a lower risk of mortality (adjusted percentage -3%, [95% CI: -5% to 0%]) than anticoagulation alone. Systemic thrombolysis was associated with a greater total cost of hospitalization ($113,043 greater [95% CI: $62,866, $163,219]). Length of hospital stay did not differ by treatment. Conclusions: Pediatric patients with PE have a high incidence of underlying chronic disease. Anticoagulation alone remains the mainstay of treatment, with thrombolysis and thrombectomy rarely being used. Given the relative rarity of pediatric PE, additional research requiring innovative study designs is paramount.

6.
Ethics Hum Res ; 46(4): 27-37, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38944884

RESUMO

The use of patient-reported outcome measures (PROMs) is increasingly common in routine clinical practice. As tools to quantify symptoms and health status, PROMs play an important role in focusing health care on outcomes that matter to patients. The uses of PROM data are myriad, ranging from clinical care to survey-based research and quality improvement. Discerning the boundaries between these use cases can be challenging for institutional review boards (IRBs). In this article, we provide a framework for classifying the three primary PROM use cases (clinical care, human subjects research, and quality improvement) and discuss the level of IRB oversight (if any) necessary for each. One of the most important considerations for IRB staff is whether PROMs are being used primarily for clinical care and thus do not constitute human subjects research. We discuss characteristics of PROMs implemented primarily for clinical care, focusing on: data platform; survey location; questionnaire length; patient interface; and clinician interface. We also discuss IRB oversight of projects involving the secondary use of PROM data that were collected during the course of clinical care, which span human subjects research and quality improvement. This framework provides practical guidance for IRB staff as well as clinicians who use PROMs as communication aids in routine clinical practice.


Assuntos
Comitês de Ética em Pesquisa , Medidas de Resultados Relatados pelo Paciente , Melhoria de Qualidade , Humanos , Comitês de Ética em Pesquisa/normas , Melhoria de Qualidade/normas , Inquéritos e Questionários/normas
7.
Health Promot Chronic Dis Prev Can ; 44(6): 244-269, 2024 Jun.
Artigo em Inglês, Francês | MEDLINE | ID: mdl-38916553

RESUMO

INTRODUCTION: Previous social prescribing work highlights a range in the types and number of outcomes used in published studies. We aimed to describe social prescribing outcome core areas and instruments to build capacity for future research and program evaluation. METHODS: This was a modified umbrella review following standard guidelines. We registered the study and searched multiple databases (all languages and years); inclusion criteria were peer-reviewed publications containing outcomes for self-described social prescribing for adults aged 18 years and older. The last search date was 9 July 2023. From the included systematic reviews, we identified primary studies using the same inclusion criteria. For primary studies, we sorted extracted outcomes and instruments into six core areas using a published taxonomy. We located information on instruments' description and measurement properties and conducted two rating rounds for (1) the quality of systematic reviews and (2) reporting of instruments in primary studies. We conducted a narrative synthesis of reviews, primary studies and outcomes (PROSPERO 2023 CRD42023434061). RESULTS: We identified 10 systematic reviews and 33 primary studies for inclusion in our review. Outcomes covered most core taxonomy areas, with an emphasis on psychosocial factors (e.g. well-being) and less emphasis on cognition, physical activity, and caregivers and volunteers. We noted few studies provided detailed information on demographic data of participants or measurement properties of instruments. CONCLUSION: This synthesis provides an overview and identifies knowledge gaps for outcomes and instruments used in social prescribing interventions. This work forms the basis of our next step of identifying social prescribing-related outcomes that matter most across interested parties, such as individuals providers and decision makers.


Assuntos
Humanos
8.
Cancer Med ; 13(12): e7253, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38899720

RESUMO

PURPOSE: Real world evidence is crucial to understanding the diffusion of new oncologic therapies, monitoring cancer outcomes, and detecting unexpected toxicities. In practice, real world evidence is challenging to collect rapidly and comprehensively, often requiring expensive and time-consuming manual case-finding and annotation of clinical text. In this Review, we summarise recent developments in the use of artificial intelligence to collect and analyze real world evidence in oncology. METHODS: We performed a narrative review of the major current trends and recent literature in artificial intelligence applications in oncology. RESULTS: Artificial intelligence (AI) approaches are increasingly used to efficiently phenotype patients and tumors at large scale. These tools also may provide novel biological insights and improve risk prediction through multimodal integration of radiographic, pathological, and genomic datasets. Custom language processing pipelines and large language models hold great promise for clinical prediction and phenotyping. CONCLUSIONS: Despite rapid advances, continued progress in computation, generalizability, interpretability, and reliability as well as prospective validation are needed to integrate AI approaches into routine clinical care and real-time monitoring of novel therapies.


Assuntos
Inteligência Artificial , Oncologia , Neoplasias , Humanos , Oncologia/métodos , Oncologia/tendências , Neoplasias/terapia
9.
Am J Transplant ; 2024 Jun 14.
Artigo em Inglês | MEDLINE | ID: mdl-38878866

RESUMO

In the general population, decreases in glomerular filtration rate (GFR) are associated with subsequent development of chronic kidney disease (CKD), cardiovascular disease (CVD), and death. It is unknown if low estimated GFR (eGFR) before or early after kidney donation was also associated with these risks. One thousand six hundred ninety-nine living donors who had both predonation and early (4-10 weeks) postdonation eGFR were included. We studied the relationships between eGFR, age at donation, and the time to sustained eGFR<45 (CKD stage 3b) and <30 mL/min/1.73m2 (CKD stage 4), hypertension, diabetes mellitus (DM), CVD, and death. Median follow-up was 12 (interquartile range, 6-21) years. Twenty-year event rates were 5.8% eGFR<45 mL/min/1.73m2; 1.2% eGFR<30 mL/min/1.73m2; 29.0% hypertension; 7.8% DM; 8.0% CVD; and 5.2% death. The median time to eGFR<45 mL/min/1.73m2 (N = 79) was 17 years, and eGFR<30 mL/min/1.73m2 (N = 22) was 25 years. Both low predonation and early postdonation eGFR were associated with eGFR<45 mL/min/1.73m2 (P < .0001) and eGFR<30 mL/min/1.73m2 (P < .006); however, the primary driver of risk for all ages was low postdonation (rather than predonation) eGFR. Predonation and postdonation eGFR were not associated with hypertension, DM, CVD, or death. Low predonation and early postdonation eGFR are risk factors for developing eGFR<45 mL/min/1.73m2 (CKD stage 3b) and <30 mL/min/1.73m2 (CKD stage 4), but not CVD, hypertension, DM, or death.

10.
Artigo em Inglês | MEDLINE | ID: mdl-38845276

RESUMO

BACKGROUND: informCLL is the largest US-based prospective, observational registry of patients with chronic lymphocytic leukemia (CLL) initiating FDA-approved treatment in the era of targeted therapy. PATIENTS AND METHODS: Patients were enrolled between October 2015 and June 2019. Data were collected for baseline characteristics, treatment patterns, outcomes, and safety. RESULTS: In total, 1459 eligible patients were enrolled (first line, n = 854; relapsed/refractory, n = 605). The most common index treatments were ibrutinib (first line, 45%; relapsed/refractory, 49%) and chemoimmunotherapy (first line, 43%; relapsed/refractory, 20%). With median follow-up of 31.8 and 30.9 months in first-line and relapsed/refractory cohorts, respectively, median time to next treatment (TTNT) in patients who received any index treatment was not reached (NR) and 48.6 months; estimated proportions without next-line therapy at 48 months were 64% and 50%. Median overall survival (OS) was NR for both cohorts; estimated 48-month OS rates were 81% and 64% in first-line and relapsed/refractory cohorts, respectively. In match-adjusted analyses, TTNT was improved with first-line ibrutinib versus chemoimmunotherapy (median NR vs. 56.5 months; hazard ratio, 0.74; 95% CI, 0.56-0.98). Exposure-adjusted rates of AEs leading to discontinuation and serious AEs were lower with ibrutinib versus chemoimmunotherapy. Estimated 36-month OS rates were similar in Black versus White patients who received any index treatment (first line, 87% vs. 83%; relapsed/refractory, 74% vs. 74%) or ibrutinib (first line, 97% vs. 85%; relapsed/refractory, 81% vs. 77%). CONCLUSION: In this prospective, large, real-world CLL registry, first-line ibrutinib was associated with longer TTNT than chemoimmunotherapy, with sustained benefit up to 4 years of follow-up.

11.
Proc (Bayl Univ Med Cent) ; 37(4): 509-515, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38910812

RESUMO

Background: Delirium is prevalent in elderly patients, linked to elevated mortality rates, heightened healthcare resource use, and caregiver burden. Inflammatory bowel disease (IBD) poses various delirium risk factors, yet the impact on geriatric IBD patient outcomes remains unexplored. Methods: Using 2016-2019 National Inpatient Sample data, we identified ≥65-year-old patients admitted for IBD (Crohn's, ulcerative colitis) management stratified by delirium presence as a secondary diagnosis. The study aimed to assess delirium's impact on geriatric IBD patient outcomes. Results: Among 67,534 elderly IBD admissions, 0.7% (470) developed delirium. The delirium group had a 4.8-fold increase in in-hospital mortality risk (odds ratio 4.80, P < 0.001, 95% confidence interval [CI] 1.94-11.8). IBD patients with delirium experienced prolonged length of stay (adjusted mean difference 5.15 days, 95% CI 3.24-7.06, P < 0.001) and increased care costs (adjusted mean difference $48,328, 95% CI $26,485-$70,171, P < 0.001) compared to those without delirium. Conclusion: Elderly IBD patients with delirium face higher mortality risk, prolonged hospitalization, and increased healthcare costs. Clinicians should recognize delirium's detrimental effects in this vulnerable group and adhere to preventive protocols for improved care.

12.
Hosp Pharm ; 59(4): 465-470, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-38919762

RESUMO

Background: Poison centers develop triage threshold guidelines for pediatric metformin ingestions. Our network uses 1700 mg, or 85 mg/kg. Objective: To describe the dose, clinical course, and outcomes for inadvertent metformin ingestions in children 5 years old and younger reported to our statewide poison center network. Methods: We searched the poison center database 2011 to 2021 for metformin ingestions in patients 5 years and younger. Variables included age, sex, weight, dose, symptoms, outcome, and more. We used descriptive statistics with medians and interquartile ranges (IQR) for continuous variables. Results: Of 669 cases, exposures by age were 208 (31.1%) 1 to 2 years, and 275 (41.1%) 2 years. Weight was recorded in 342 (51.1%) (median 13.5 kg; IQR: 3.7 kg), and dose in 149 (22.3%) (median 500 mg; IQR: 500 mg). Milligram/kilogram values were available for 103 (15.4%) with median 42.4 mg/kg, IQR: 39 mg/kg. Most (647, 98.5%) exposures were unintentional. Most (445/669, 66.5%) were managed at a non-healthcare facility, while 204 (30.7%) were already at or referred to a healthcare facility. Of these 204 patients, 169 (82.8%) were evaluated and treated at the emergency department and discharged. Four (2%) were admitted to critical care, and 7 (3.4%) to the ward. Medical outcomes by effect were 5 (0.7%) minor, 2 (0.3%) moderate, 253 (37.8%) none, 292 (43.6%) not followed (minimal effects possible), and no major effects or deaths. Of 20 clinical occurrences reported, vomiting was most common (8, 1.2%). Conclusion: Despite little recorded dosage information, pediatric metformin ingestions under 85 mg/kg had predominantly uneventful medical outcomes.

13.
Artigo em Inglês | MEDLINE | ID: mdl-38716773

RESUMO

OBJECTIVE: To assess perioperative and readmission outcomes of patients undergoing head and neck cancer (HNCA) surgery at safety-net hospitals (SNHs) in a modern cohort. STUDY DESIGN: Retrospective cohort study. SETTING: Nationwide Readmissions Database (NRD), 2010 to 2019. METHODS: All elective adult (≥18 years) admissions involving HNCA resection were identified from the NRD. To calculate safety-net burden, the proportion of Medicaid or uninsured patients admitted to each hospital for any indication was tabulated annually, with centers in the highest quartile defined as SNHs. To perform risk adjustment in assessing perioperative and readmission outcomes, multivariable regression models were developed. RESULTS: Of an estimated 133,018 head and neck surgical patients, 26.5% (n = 35,268) received treatment at a SNH. Utilization of SNHs increased over the decade-long study period, with 29.8% of individuals treated at these sites in 2019. After multivariable adjustment, several patient factors were noted to be associated with SNHs, including younger age, lower comorbidity burden, and income within the lowest quartile. Although incidence of adverse events decreased at both SNHs and non-SNHs during the study period, treatment at SNHs remained associated with these events after risk adjustment (adjusted odds ratio: 1.17, 95% confidence interval: 1.08-1.28, P < .001). CONCLUSION: SNHs continue to provide valuable specialty care to underserved populations, often with limited financial resources. Despite promising results from prior decades demonstrating comparable perioperative outcomes, the present study noted increased adverse events following HNCA surgery at these sites. Such findings underscore the need for continued advocacy to secure necessary funding for these centers.

14.
BMC Health Serv Res ; 24(1): 601, 2024 May 08.
Artigo em Inglês | MEDLINE | ID: mdl-38714970

RESUMO

BACKGROUND: Previous studies found that documentation of comorbidities differed when Veterans received care within versus outside Veterans Health Administration (VHA). Changes to medical center funding, increased attention to performance reporting, and expansion of Clinical Documentation Improvement programs, however, may have caused coding in VHA to change. METHODS: Using repeated cross-sectional data, we compared Elixhauser-van Walraven scores and Medicare Severity Diagnosis Related Group (DRG) severity levels for Veterans' admissions across settings and payers over time, utilizing a linkage of VHA and all-payer discharge data for 2012-2017 in seven US states. To minimize selection bias, we analyzed records for Veterans admitted to both VHA and non-VHA hospitals in the same year. Using generalized linear models, we adjusted for patient and hospital characteristics. RESULTS: Following adjustment, VHA admissions consistently had the lowest predicted mean comorbidity scores (4.44 (95% CI 4.34-4.55)) and lowest probability of using the most severe DRG (22.1% (95% CI 21.4%-22.8%)). In contrast, Medicare-covered admissions had the highest predicted mean comorbidity score (5.71 (95% CI 5.56-5.85)) and highest probability of using the top DRG (35.3% (95% CI 34.2%-36.4%)). CONCLUSIONS: More effective strategies may be needed to improve VHA documentation, and current risk-adjusted comparisons should account for differences in coding intensity.


Assuntos
Comorbidade , Hospitais de Veteranos , Índice de Gravidade de Doença , Humanos , Estudos Transversais , Estados Unidos/epidemiologia , Masculino , Feminino , Idoso , Hospitais de Veteranos/estatística & dados numéricos , Pessoa de Meia-Idade , Grupos Diagnósticos Relacionados/estatística & dados numéricos , United States Department of Veterans Affairs/estatística & dados numéricos , Medicare/estatística & dados numéricos , Idoso de 80 Anos ou mais , Veteranos/estatística & dados numéricos
16.
Catheter Cardiovasc Interv ; 104(1): 34-43, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38713867

RESUMO

Hypertension continues to be a prominent, avoidable factor contributing to major vascular issues on a global scale. Even with lifestyle adjustments and more aggressive medical treatments, maintaining optimal blood pressure levels remains challenging. This challenge has driven the emergence of device-oriented approaches to address hypertension. To assess the safety and efficacy of the Recor Paradise Ultrasound Renal Denervation System, the Circulatory System Devices Panel was convened by the US Food and Drug Administration (FDA). This manuscript provides a condensed overview of the information put forth by the sponsor and the FDA, along with an account of the considerations and conversations that took place during the meeting.


Assuntos
Pressão Sanguínea , Aprovação de Equipamentos , Hipertensão , Artéria Renal , Simpatectomia , United States Food and Drug Administration , Humanos , Estados Unidos , Simpatectomia/efeitos adversos , Simpatectomia/instrumentação , Hipertensão/fisiopatologia , Hipertensão/cirurgia , Artéria Renal/inervação , Artéria Renal/diagnóstico por imagem , Resultado do Tratamento , Rim/irrigação sanguínea , Comitês Consultivos , Desenho de Equipamento , Fatores de Risco
17.
Future Sci OA ; 10(1): FSO930, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38817364

RESUMO

Aim: This meta-analysis aims to shed light on any primacy the trans-carotid (TC-TAVR) access may have over the trans-femoral access (TF-TAVR) for those undergoing transcatheter aortic valve replacement (TAVR). Methods: PubMed/MEDLINE and Cochrane Library were searched, from inception to March 2023 retrieving seven adjusted studies with a total of 6609 patients, of which 5048 underwent TF-TAVR while 1561 underwent TC-TAVR. Results: No divergence in risk of mortality, major bleeding or stroke/transient ischemic attack in TC-TAVR when compared with TF-TAVR was found. In TC-TAVR, the risk of vascular complications was low (OR: 0.51, 95% CI: 0.32-0.83, p = 0.003) as compared with TF-TAVR. Conclusion: As of this analysis, the viability of TC-TAVR as first alternative to TF-TAVR is plausible.

18.
Rheumatol Adv Pract ; 8(2): rkae057, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38800575

RESUMO

Objective: To analyse patients with RA for inflammatory activity by physician estimate of global assessment (DOCGL) vs an estimate of inflammatory activity (DOCINF) to explain variation in the swollen joint count (SJC). Methods: Patients with RA were studied at routine care visits. Patients completed a multidimensional health assessment questionnaire (MDHAQ) and the physician completed a 28-joint count for swollen (SJC), tender (TJC) and deformed (DJC) joints and a RheuMetric checklist with a 0-10 DOCGL visual numeric scale (VNS) and 0-10 VNS estimates of inflammation (DOCINF), damage (DOCDAM) and patient distress (DOCSTR). The disease activity score in 28 joints with ESR (DAS28-ESR), Clinical Disease Activity Index (CDAI) and Routine Assessment of Patient Index Data 3 (RAPID3) were calculated. Individual scores and RA indices were compared according to Spearman correlation coefficients and regression analyses. Results: A total of 104 unselected patients were included, with a median age and disease duration of 54.5 and 5 years, respectively. The median DAS28-ESR was 2.9 (Q1-Q3: 2.0-3.7), indicating low activity. DOCINF was correlated significantly with DOCGL (ρ = 0.775). Both DOCGL and DOCINF were correlated significantly with most other measures; correlations with DOCGL were generally higher than with DOCINF other than for SJC. In regression analyses, DOCINF was more explanatory of variation in SJC than DOCGL and other DAS28-ESR components. Conclusions: Variation in SJC is explained more by a 0-10 DOCINF VNS than the traditional DOCGL or any other measure in RA patients seen in routine care. DOCINF on a RheuMetric checklist can provide informative quantitative scores concerning inflammatory activity in RA patients monitored over long periods.

19.
Hosp Pharm ; 59(3): 300-309, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38765000

RESUMO

Background: Infectious diseases (ID) pharmacists are pivotal members of antimicrobial stewardship teams. Prospective audit and feedback is a strong recommendation by The Infectious Diseases Society of America Guidelines for Antimicrobial Stewardship Programs (ASP). Utilizing customized ASP intervention documentation tools known as "ivents" in Epic, we aimed to assess the impact of interventions by measuring outcomes that were accepted compared to those that were rejected in a multihospital health system over 5 years. Methods: A multicenter, retrospective cohort study was conducted to compare clinical outcomes among intensive care unit (ICU) and non-ICU patients with accepted and rejected ASP interventions over 5 years from October 2015 to December 2020. Outcomes measured included antibiotic days of therapy per 1000 patient days (DOT/1000 PD), antibiotic doses per 1000 patient days (doses/1000 PD), hospital length of stay (LOS), in-hospital mortality, hospital-acquired Clostridioides difficile infection (HA-CDI), community-onset C. difficile infection (CO-CDI) within 30 days, and hospital readmission within 30 days. Coarsened exact matching (CEM) was used as a non-parametric matching method to balance covariates between groups and to control for confounding. Results: ASP recommendations by ID pharmacists were well-received by providers in a multihospital system over 5 years as evidenced by an overall acceptance rate of 92%. Acceptance of ASP interventions was associated with substantial reductions in antibiotic utilization without adversely affecting mortality or hospital readmissions. While high-risk C. difficile antibiotic use increased significantly due to frequent de-escalation to ceftriaxone among non-ICU patients with accepted interventions, rates of HA-CDI and CO-CDI within 30 days did not worsen. Furthermore, hospital LOS was notably shorter by an average of 1 day for non-ICU patients with accepted interventions, which resulted in substantial cost avoidance of $7 631 400. Conclusion: Collaboration with ID pharmacists to optimize antimicrobial stewardship was associated with significant reductions in antibiotic utilization, costs, and hospital LOS without worsening patient outcomes.

20.
Hosp Pharm ; 59(3): 359-366, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38764999

RESUMO

Background: Volume overload (VO) is common in the intensive care unit (ICU) and associated with negative outcomes. Approaches have been investigated to curtail VO; however, none specifically focused on medication diluent volume optimization. Objective: Investigate the impact of a pharmacist-driven medication diluent volume optimization protocol on fluid balance in critically ill patients. Methods: A prospective, pilot study was conducted in a medical ICU during October 2021 to December 2021 (pre) and February 2022 to April 2022 (post). A pharmacist-driven medication diluent volume optimization protocol focusing on vasopressor and antimicrobial diluent volumes was implemented. Demographics and clinical data were collected during ICU admission up to 7 days. The primary outcome was net fluid balance on day 3. Secondary outcomes were medication volumes administered, net fluid balance, ICU length of stay, and mortality. Results: Supply chain shortages caused the study to stop at the end of February 2022. Overall, 152 patients were included (123 pre group, 29 post group). The most common admission diagnosis was acute respiratory failure (35%). Vasopressors and antimicrobials were utilized in 47% and 66% of patients, respectively. Net fluid balance on day 3 was greater but not significant in the post group (227.1 mL [-1840.3 to 3483.7] vs 2012.3 mL [-2686.0 to 4846.0]; P = .584). Antimicrobial diluent volumes were significantly less in the post group. No differences were seen in other secondary outcomes. Protocol group assignment was not associated with net fluid balance on day 3. Conclusion: Despite decreasing antimicrobial volume contributions, optimizing diluent volumes alone did not significantly impact overall volume status. Future studies should focus on comprehensive approaches to medication diluent optimization and fluid stewardship.

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