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"Anand, Sarah"
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Risk of venous thromboembolism associated with peripherally inserted central catheters: a systematic review and meta-analysis
by
Anand, Sarah
,
Flanders, Scott A
,
Rogers, Mary AM
in
Adult
,
adults
,
Biological and medical sciences
2013
Peripherally inserted central catheters (PICCs) are associated with an increased risk of venous thromboembolism. However, the size of this risk relative to that associated with other central venous catheters (CVCs) is unknown. We did a systematic review and meta-analysis to compare the risk of venous thromboembolism associated with PICCs versus that associated with other CVCs.
We searched several databases, including Medline, Embase, Biosis, Cochrane Central Register of Controlled Trials, Conference Papers Index, and Scopus. Additional studies were identified through hand searches of bibliographies and internet searches, and we contacted study authors to obtain unpublished data. All human studies published in full text, abstract, or poster form were eligible for inclusion. All studies were of adult patients aged at least 18 years who underwent insertion of a PICC. Studies were assessed with the Newcastle–Ottawa risk of bias scale. In studies without a comparison group, the pooled frequency of venous thromboembolism was calculated for patients receiving PICCs. In studies comparing PICCs with other CVCs, summary odds ratios (ORs) were calculated with a random effects meta-analysis.
Of the 533 citations identified, 64 studies (12 with a comparison group and 52 without) including 29 503 patients met the eligibility criteria. In the non-comparison studies, the weighted frequency of PICC-related deep vein thrombosis was highest in patients who were critically ill (13·91%, 95% CI 7·68–20·14) and those with cancer (6·67%, 4·69–8·64). Our meta-analysis of 11 studies comparing the risk of deep vein thrombosis related to PICCs with that related to CVCs showed that PICCs were associated with an increased risk of deep vein thrombosis (OR 2·55, 1·54–4·23, p<0·0001) but not pulmonary embolism (no events). With the baseline PICC-related deep vein thrombosis rate of 2·7% and pooled OR of 2·55, the number needed to harm relative to CVCs was 26 (95% CI 13–71).
PICCs are associated with a higher risk of deep vein thrombosis than are CVCs, especially in patients who are critically ill or those with a malignancy. The decision to insert PICCs should be guided by weighing of the risk of thrombosis against the benefit provided by these devices.
None.
Journal Article
Comparing 2-day vs 3-day flu-CY lymphodepleting regimens for CD19 CAR T-cell therapy in patients with non-hodgkin’s lymphoma
by
Pawarode, Attaphol
,
Oberfeld, Avery
,
Ghosh, Monalisa
in
Adult
,
Aged
,
Antigens, CD19 - immunology
2024
Lymphodepleting chemotherapy (LDC) is critical to CAR T-cell expansion and efficacy. Despite this, there is not a consensus in the literature regarding the optimal LDC regimen, including dose and frequency.
We retrospectively reviewed consecutive patients at a single institution that received LDC prior to treatment with the CD19 directed CAR T-cell products axicabtagene ciloleucel and tisagenlecleucel. Patients treated at our center received fludarabine 30 mg/m
and cyclophosphamide 500 mg/m
for 3 consecutive days prior to May 2019. After this timepoint patients routinely received fludarabine 40 mg/m
and cyclophosphamide 500 mg/m
for 2 consecutive days. Clinical data from each cohort were obtained from the electronic medical record and compared for differences in CAR T-cell efficacy and toxicity.
From June 2018 to August 2023, LDC was given to 92 patients prior to CD19 directed CAR T-cell therapy for relapsed non-Hodgkin's lymphoma. Twenty-eight patients received a 3-day regimen, and 64 patients received a 2-day regimen. In the total cohort, 75% of patients received axicabtagene ciloleucel and 25% received tisagenlecleucel. The overall response rates in both the 2-day regimen group and the 3-day regimen group were similar (69% vs 75%, p= 0.21) as were the complete response rates (50% vs 54%, p=0.82). There were no significant differences between the 2-day and 3-day regimens for grade 2-4 cytokine release syndrome (55% vs 50%, p=0.82), grade 2-4 immune effector cell associated-neurotoxicity syndrome (42% vs 29%, p=0.25), or time to resolution of neutropenia or thrombocytopenia. The rate of prolonged platelet recovery lasting greater than 60 days was higher with the 3-day regimen (9% vs 27%, p=0.026).
As the number of patients eligible for CAR T-cell therapy continues to increase, optimizing each component of therapy is necessary. We show that a 2-day regimen of LDC with fludarabine and cyclophosphamide is feasible without significant impact on CAR T-cell efficacy or toxicity. Prospective studies are necessary to further determine the most effective LDC regimen.
Journal Article
Feasibility of a dietary intervention to modify gut microbial metabolism in patients with hematopoietic stem cell transplantation
2023
Evaluation of the impact of dietary intervention on gastrointestinal microbiota and metabolites after allogeneic hematopoietic stem cell transplantation (HCT) is lacking. We conducted a feasibility study as the first of a two-phase trial. Ten adults received resistant potato starch (RPS) daily from day −7 to day 100. The primary objective was to test the feasibility of RPS and its effect on intestinal microbiome and metabolites, including the short-chain fatty acid butyrate. Feasibility met the preset goal of 60% or more, adhering to 70% or more doses; fecal butyrate levels were significantly higher when participants were on RPS than when they were not (
P
< 0.0001). An exploratory objective was to evaluate plasma metabolites. We observed longitudinal changes in plasma metabolites compared to baseline, which were independent of RPS (
P
< 0.0001). However, in recipients of RPS, the dominant plasma metabolites were more stable compared to historical controls with significant difference at engraftment (
P
< 0.05). These results indicate that RPS in recipients of allogeneic HCT is feasible; in this study, it was associated with significant alterations in intestinal and plasma metabolites. A phase 2 trial examining the effect of RPS on graft-versus-host disease in recipients of allogeneic HCT is underway. ClinicalTrials.gov registration:
NCT02763033
.
In a pilot feasibility study involving recipients of allogeneic hematopoietic stem cell transplants, adherence to a dietary intervention and its effects on the gut microbiota were assessed in the run-in to a study testing the effects of modulation of the microbiome on transplant outcomes.
Journal Article
Disease risk and GVHD biomarkers can stratify patients for risk of relapse and nonrelapse mortality post hematopoietic cell transplant
by
Ferrara James L M
,
Etra Aaron
,
Srinagesh Hrishikesh
in
Algorithms
,
Biomarkers
,
Graft-versus-host reaction
2020
The graft-versus-leukemia (GVL) effect after allogeneic hematopoietic cell transplant (HCT) can prevent relapse but the risk of severe graft-versus-host disease (GVHD) leads to prolonged intensive immunosuppression and possible blunting of the GVL effect. Strategies to reduce immunosuppression in order to prevent relapse have been offset by increases in severe GVHD and nonrelapse mortality (NRM). We recently validated the MAGIC algorithm probability (MAP) that predicts the risk for severe GVHD and NRM in asymptomatic patients using serum biomarkers. In this study we tested whether the MAP could identify patients whose risk for relapse is higher than their risk for severe GVHD and NRM. The multicenter study population (n = 1604) was divided into two cohorts: historical (2006–2015, n = 702) and current (2015–2017, n = 902) with similar NRM, relapse, and survival. On day 28 post-HCT, patients who had not developed GVHD (75% of the population) and who possessed a low MAP were at much higher risk for relapse (24%) than severe GVHD and NRM (16 and 9%); this difference was even more pronounced in patients with a high disease risk index (relapse 33%, NRM 9%). Such patients are good candidates to test relapse prevention strategies that might enhance GVL.
Journal Article
Director-Led Investigations
2019
When allegations raise concerns about C-suite or systemic matters broadly affecting a company, the duty to investigate typically becomes a responsibility of the board of directors, often through the audit committee or a special committee (referred to here as the \"investigative committee\"). See Joan E. Meyers & Maria McMahon, Hidden Dangers in the Early Stages of an Internal Investigation 1 (presented at the ABA Section of Litigation 2016 Corporate Counsel CLE Seminar) (noting that \"the number one pitfall\" observed is companies not reacting quickly enough at the outset of an internal investigation). [...]it is important for the investigative committee to quickly identify and retain outside counsel who is experienced in conducting investigations. If so, specialized experts may be critical team members. * Do the allegations affect the organization's reporting of its financial results? * If so, it is important to have a forensic accounting team's expertise, consisting of special skills in auditing, accounting, and analytical techniques, to effectively evaluate the evidence and underlying issues and to assist in discussions with outside auditors, regulators, and third parties. * Do the experts have the appropriate industry, business process, regulatory, and compliance expertise, as well as significant investigative experience? Allegations of potential wrongdoing can arise in a variety of ways: an employee complaint or hotline tip; an auditor question or concern; a shareholder claim; an outside inquiry from a regulator, such as the Securities and Exchange Commission or a state attorney general; or a media report of misconduct.
Journal Article
DIRECTOR-LED INVESTIGATIONS
2021
When allegations raise concerns about C-suite or systemic matters broadly affecting a company, the duty to investigate typically becomes a responsibility of the board of directors, often through the audit committee or a special committee (referred to here as the \"investigative committee\"). Two key components in the process are (1) taking proper care of the attorney-client privilege and (2) firmly establishing that counsel represents the corporate entity or the board and not individual witnesses or company personnel. Immediately implement the company's document retention policy and ensure it functions as intended; suspend any routine document destruction; (2) Document preservation period:
Magazine Article
Communication Centers and Oral Communication Programs in Higher Education
by
Atkins-Sayre, Wendy
,
Yook, Eunkyong Lee
in
College dropouts
,
Communication
,
EDUCATION / Language Experience Approach bisacsh
2013,2012
Communication Centers and Oral Communication Programs in Higher Education, edited by Eunkyong L.Yook and Wendy Atkins-Sayre, is a collection that examines the centers that support communication departments or across-the-curriculum programs as higher education focuses more attention on the communication field.