Prospective cohort study of the impact of hospital-wide dihydropyrimidine dehydrogenase (DPYD) genotype testing for fluoropyrimidine-based chemotherapy on adverse events and hospital costs.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 3028-3028
Author(s):  
Theodore John Wigle ◽  
Brandi Povitz ◽  
Wendy Teft ◽  
Robin Legan ◽  
John Gordon Lenehan ◽  
...  
Keyword(s):  
Adverse Events ◽  
Health Care Providers ◽  
Prospective Cohort ◽  
Primary Outcome ◽  
Dihydropyrimidine Dehydrogenase ◽  
Care Providers ◽  
Wild Type ◽  
Significant Difference ◽  
Grade 3 ◽  
The Impact

3028 Background: Fluoropyrimidines remain integral components of modern chemotherapy for solid tumors, and their toxicities can be reduced by pretreatment DPYD genotyping. Our main objective was to demonstrate the feasibility of implementing a hospital-wide pretreatment DPYD testing service based on the CPIC 2013 guideline on fluoropyrimidines and DPYD. Methods: We enrolled participants prior to planned fluoropyrimidine treatment as well as those who had experienced adverse events (AEs) after initiation of therapy, from December 1, 2013 to November 30, 2018. The patients tested pretreatment were analyzed as a prospective cohort to assess AEs within 90 days of fluoropyrimidine initiation and associated hospital cost. The primary outcome was the rate of severe global fluoropyrimidine-related toxicity in the pretreatment cohort (grade≥3, CTCAE v.4.0.3). Results: Of 1362 patients genotyped for DPYD within the study period 1041 were enrolled pretreatment and included in the primary analysis. The median age was 65 years (19-90), 57% male, 51% 5-FU, and 49% capecitabine. Dose reductions were recommended for 21 DPYD variant carriers who were detected pretreatment. There was no significant difference in the primary outcome between DPYD variant (29%) and wild type (18%) patients (Fisher’s exact test p = 0.25). Costs associated with ER visits and hospitalizations at our tertiary care centre were $1,268 (89-8,562) (Median (IQR)) and $2,961 (341-13,567) for DPYD variant (n = 4) and wild-type (n = 99) patients respectively. Post-AE genotyping (n = 70) found five DPYD variant patients; all experienced grade≥3 toxicity, costs were $15,825 (10,962-25,310), and one poor metabolizer died due to complications. Targeted next generation exome sequencing of DPYD wild-type patients who experienced severe AEs identified five potentially deleterious genetic variants in ABC efflux transporters. Conclusions: Pretreatment DPYD genotype guided dosing of fluorouracil and capecitabine is feasible and benefits patients, health care providers, and hospitals. Our data supports adoption of pretreatment DPYD genotyping as a standard of care.

scholarly journals The Effect of "Pathway" to Diagnosis for Childhood ITP on Caregiver Quality of Life at Time of Diagnosis

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2174-2174
Author(s):  
Michelle Neier ◽  
Michele P. Lambert ◽  
Rachael F. Grace ◽  
Kerry Hege ◽  
Stephanie Chiu ◽  
...  
Keyword(s):  
Health Care ◽  
Health Care Provider ◽  
Health Care Providers ◽  
Care Provider ◽  
Research Funding ◽  
Care Providers ◽  
Significant Difference ◽  
Time To Diagnosis ◽  
The Impact

Background: Immune thrombocytopenia (ITP) is an immune mediated bleeding disorder characterized by isolated thrombocytopenia. ITP can have a variety of presentations from asymptomatic to life threatening bleeding. Although childhood ITP is most often a self-resolving illness which can be closely observed without intervention, it can be associated with significant impact on quality of life (QoL). Prospective studies of QoL in ITP patients show that there is not always a correlation with treatment or disease severity. The pathway from initial presentation to final diagnosis varies and may include encounters with emergency room, primary care or specialty providers. There have been no published studies to date showing the impact of factors prior to the diagnosis of ITP on treatment decision making and QoL. Objective: To identify the role of physician-patient and physician-caregiver interactions on the QoL and emotional well-being of patients and their families. Ascertaining the impact of pre-diagnosis factors may provide an opportunity to improve access and quality of care provided. Methods: The ITP Consortium of North America (ICON) "Pathways" study was a multicenter observational prospective cohort study focused on the pathways to diagnosis of ITP. The study was supported by a Foundation for Morristown Medical Center Research Fund Grant. Subjects were included if they had presumed primary ITP and were age >12 months to <18 years. Subjects were excluded if they had secondary ITP, including Evans syndrome. Treatment was determined by the physician. Subjects were consented and presented with questionnaires to be completed at the conclusion of the initial hematology visit. The hematologist also completed survey data at that time. Survey data forms included demographic form, physician form, Peds QL Family Impact Questionnaire, Kids ITP tools (KIT) Parent Impact Report and parent proxy report, and child (patient) KIT self-report. There was a parent questionnaire which included a question about worry with a scale from 0 to 10. Study data were collected and managed using REDCap electronic data capture tools hosted at Atlantic Health System. Correlation between variables were calculated using Pearson coefficient or Spearman's rho depending on the distribution of the data variables. Results: Sixty subjects and caregivers were enrolled at 6 ICON centers; 52 were eligible for inclusion. The majority (40%) had Grade 1 bleeding. Most patients (82%) were seen in outpatient hematology clinic by the hematologist and had been referred by the emergency room (73%). The median time to consultation with a hematologist from onset of symptoms was 7 days (1-199) and the median time to diagnosis by hematologist from initial contact with a health care provider was 5 days (0-154). Most subjects had seen 2 health care providers prior to the hematologist. KIT proxy report cumulative scores were a mean of 76.03 (SD 14.72). There was no significant difference between the time to diagnosis or the time from initial encounter with health care provider to hematologist and initial level of worry (p=0.70 and 0.90, respectively). There was also no significant difference between the time to diagnosis or the time from initial encounter with health care provider to hematologist and KIT proxy scores (p=0.96 and 0.50, respectively). However, there was a significant decline in level of worry (scale 0-10) prior to the hematologist visit (median 8, range 1-10) to after the visit (median 4, range 1-10). The association between number of medical providers encountered prior to diagnosis and KIT proxy scores was not significant (p=0.45) (Table). Conclusions: In this study at 6 teaching institutions, we were unable to detect a significant difference in proxy-reported KIT scores relative to the number of health care providers seen or time from diagnosis until the first encounter with the hematologist. We were, however, able to detect a significant change in the level of caregiver worry pre- and post- visit with the pediatric hematologist, supporting a benefit of specialist care to the caregivers of children with ITP. This study was limited by its small sample size and retrospective design. ITP is considered a benign disease but is associated with a significant amount of worry and impact on QoL for patients and caregivers which warrants further investigation. Disclosures Lambert: CSL Behring: Consultancy; Amgen: Consultancy, Other; Bayer: Other: Ad boards; Novartis: Other: Ad boards, Research Funding; Shionogi: Consultancy; Kedrion: Consultancy; Sysmex: Consultancy; AstraZeneca: Research Funding; PDSA: Research Funding. Grace:Agios Pharmaceuticals, Inc: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Research Funding.

Immune-related adverse events associated with immune checkpoint inhibitors in patients with cancer

2020 ◽  
pp. 030089162095346
Author(s):  
Nilay Sengul Samanci ◽  
Duygu Ilke Cikman ◽  
Kerem Oruc ◽  
Sahin Bedir ◽  
Emir Çelik ◽  
...  
Keyword(s):  
Adverse Events ◽  
Health Care Providers ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Early Recognition ◽  
Care Providers ◽  
Patients With Cancer ◽  
Combination Treatments ◽  
Grade 3

Introduction: With the widespread use of immune checkpoint inhibitors (ICIs), we are facing challenges in the management of immune-related adverse events (irAEs). We aimed to characterize the spectrum of toxicity, management, and outcomes for irAEs. Methods: Patients who were treated with at least one ICI in clinical trials, expanded access programs, or routine clinical practice were included. Clinical and laboratory parameters were collected retrospectively to determine the incidence of irAEs, methods of management, and treatment outcomes. Results: A total of 255 patients were screened retrospectively. Of these, 71 (27.8%) patients developed irAEs. More than 2 different types of irAEs were detected in 16 (6.2%) out of 255 patients. A total of 3177 doses were given to 255 patients. In 93 (2.9%) of the 3177 doses, 1 episode of irAEs was experienced. A total of 22 out of 93 (23.7%) episodes were reported as grade 1, 49 (52.7%) as grade 2, 19 (20.4%) as grade 3, and 3 (3.2%) as grade 4. The most frequently seen irAEs were pneumonitis, hepatitis, and hypothyroidism. With regard to treatment, 39 out of 93 episodes (42%) of any grade irAEs occurred after anti–programmed cell death-1 therapy, 47 (50.5%) occurred following administration of anti–programmed death-ligand 1, and 7 (7.5%) occurred after combination treatments. Conclusion: With the increased use of immunotherapeutic agents, increased awareness and early recognition are required for effective management of irAEs. Our experience as a single institution might be of use for health care providers in oncology.

scholarly journals Predictive Value of Clinical Toxicities to Chemotherapy with Fluoropyrimidines and Oxaliplatin in Colorectal Cancer by DPYD and GSTP1 Genes Polymorphisms

2020 ◽  
Author(s):  
Xunwei Deng ◽  
Jingyuan Hou ◽  
Qiaoting Deng ◽  
Zhixiong Zhong
Keyword(s):  
Colorectal Cancer ◽  
Adverse Events ◽  
Direct Sequencing ◽  
Dihydropyrimidine Dehydrogenase ◽  
Severe Neutropenia ◽  
Severe Toxicity ◽  
Nucleotide Polymorphisms ◽  
Significant Difference ◽  
Grade 3 ◽  
Colorectal Cancer Patients

Abstract Background: Fluoropyrimidines and platinum are still widely used for colorectal cancer (CRC) management. Several studies have reported that mutations of dihydropyrimidine dehydrogenase (DPYD) and glutathione S-transferase pi-1 (GSTP1) polymorphisms are related to Chemotherapy-related adverse events. The present study was aimed to determine the role of DPYD and GSTP1 variants on patient chemotherapy toxicity risk among the Hakka population, minimize adverse events and in order to maximize therapy outcome for individualized treatment.Methods: Genotyping was examined in 104 patients diagnosed with CRC cases and receiving fluoropyrimidine and platinum drugs based chemotherapy regimen by direct sequencing of DPYD and GSTP1 polymorphisms. Three DPYD variants including *2A, *5A, *9A and GSTP1 c.313A>G were analyzed and clinical outcomes were assessed. Results: The data suggest that the incidence of DPYD*5A, DPYD*9A and GSTP1 c.313A>G variants were 37.5%, 24% and 31.7%, respectively. DPYD*2A variant was not found. A total of 38 patients (36.5%) suffered severe neutropenia and 23 patients (22.1%) suffered severe vomiting. DPYD*5A polymorphism was found significantly associated with grade 3/4 ulceration (p = 0.001). GSTP1 was determined to be an independent risk factor for severe neutropenia and ulceration (p = 0.010 and p = 0.034, respectively). Patients with GSTP1 c.313A>G wild type contributed to higher risk for grade severe toxicity compared with A/G + G/G genotype (p = 0.024). However, there was no significant difference between patients with DPYD*9A T/T and T/C + C/C genotype for chemotherapeutic toxicity.Conclusions: The results demonstrated that DPYD*5A and GSTP1 polymorphisms were useful predictors for severe events. Screening of single nucleotide polymorphisms of DPYD and GSTP1 in colorectal cancer patients prior to chemotherapy may help to realize personalized therapy.

scholarly journals Effectiveness of an Electronic Communication Tool on Transitions in Care From the Intensive Care Unit: Protocol for a Cluster-Specific Pre-Post Trial (Preprint)

2020 ◽  
Author(s):  
Jeanna Parsons Leigh ◽  
Rebecca Brundin-Mather ◽  
Liam Whalen-Browne ◽  
Devika Kashyap ◽  
Khara Sauro ◽  
...  
Keyword(s):  
Health Care ◽  
Intensive Care ◽  
Health Care Providers ◽  
Primary Outcome ◽  
Audit And Feedback ◽  
Free Text ◽  
Care Providers ◽  
Transitions In Care ◽  
Post Trial ◽  
The Impact

BACKGROUND Transitions in care are vulnerable periods in health care that can expose patients to preventable errors due to incomplete or delayed communication between health care providers. Transitioning critically ill patients from intensive care units (ICUs) to other patient care units (PCUs) is particularly risky, due to the high acuity of the patients and the diversity of health care providers involved in their care. Instituting structured documentation to standardize written communication between health care providers during transitions has been identified as a promising means to reduce communication breakdowns. We developed an evidence-informed, computer-enabled, ICU-specific structured tool—an electronic transfer (e-transfer) tool—to facilitate and standardize the composition of written transfer summaries in the ICUs of one Canadian city. The tool consisted of 10 primary sections with a user interface combination of structured, automated, and free-text fields. OBJECTIVE Our overarching goal is to evaluate whether implementation of our e-transfer tool will improve the completeness and timeliness of transfer summaries and streamline communications between health care providers during high-risk transitions. METHODS This study is a cluster-specific pre-post trial, with randomized and staggered implementation of the e-transfer tool in four hospitals in Calgary, Alberta. Hospitals (ie, clusters) were allocated randomly to cross over every 2 months from control (ie, dictation only) to intervention (ie, e-transfer tool). Implementation at each site was facilitated with user education, point-of-care support, and audit and feedback. We will compare transfer summaries randomly sampled over 6 months postimplementation to summaries randomly sampled over 6 months preimplementation. The primary outcome will be a binary composite measure of the timeliness and completeness of transfer summaries. Secondary measures will include overall completeness, timeliness, and provider ratings of transfer summaries; hospital and ICU lengths of stay; and post-ICU patient outcomes, including ICU readmission, adverse events, cardiac arrest, rapid response team activation, and mortality. We will use descriptive statistics (ie, medians and means) to describe demographic characteristics. The primary outcome will be compared within each hospital pre- and postimplementation using separate logistic regression models for each hospital, with adjustment for patient characteristics. RESULTS Participating hospitals were cluster randomized to the intervention between July 2018 and January 2019. Preliminary extraction of ICU patient admission lists was completed in September 2019. We anticipate that evaluation data collection will be completed by early 2021, with first results ready for publication in spring or summer 2021. CONCLUSIONS This study will report the impact of implementing an evidence-informed, computer-enabled, ICU-specific structured transfer tool on communication and preventable medical errors among patients transferred from the ICU to other hospital care units. CLINICALTRIAL ClinicalTrials.gov NCT03590002; https://www.clinicaltrials.gov/ct2/show/NCT03590002 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/18675

The Impact of Personal Protection Equipment on Intubation Times

2021 ◽  
pp. 1-5
Author(s):  
Donald Doukas ◽  
Bonnie Arquilla ◽  
Pinchas Halpern ◽  
Mark Silverberg ◽  
Richard Sinert
Keyword(s):  
Health Care Providers ◽  
Controlled Trial ◽  
Size Analysis ◽  
Care Providers ◽  
Personal Protection Equipment ◽  
Study Objective ◽  
Exact Test ◽  
Significant Difference ◽  
Multiple Levels ◽  
The Impact

Abstract Introduction: Hazardous material (HAZMAT) protocols require health care providers to wear personal protective equipment (PPE) when caring for contaminated patients. Multiple levels of PPE exist (level D - level A), providing progressively more protection. Emergent endotracheal intubation (ETI) of victims can become complicated by the cumbersome nature of PPE. Study Objective: The null hypothesis was tested that there would be no difference in time to successful ETI between providers in different types of PPE. Methods: This randomized controlled trial assessed time to ETI with differing levels of PPE. Participants included 18 senior US Emergency Medicine (EM) residents and attendings, and nine US senior Anesthesiology residents. Each individual performed ETI on a mannequin (Laerdal SimMan Essential; Stavanger, Sweden) wearing the following levels of PPE: universal precautions (UP) controls (nitrile gloves and facemask with shield); partial level C (PC; rubber gloves and a passive air-purifying respirator [APR]); and complete level C (CC; passive APR with an anti-chemical suit). Primary outcome measures were the time in seconds (s) to successful intubation: Time 1 (T1) = inflation of the endotracheal tube (ETT) balloon; Time 2 (T2) = first ventilation. Data were reported as medians with Interquartile Ranges (IQR, 25%-75%) or percentages with 95% Confidence Intervals (95%, CI). Group comparisons were analyzed by Fisher’s Exact Test or Kruskal-Wallis, as appropriate (alpha = 0.017 [three groups], two-tails). Sample size analysis was based upon the power of 80% to detect a difference of 10 seconds between groups at a P = .017; 27 subjects per group would be needed. Results: All 27 participants completed the study. At T1, there was no statistically significant difference (P = .27) among UP 18.0s (11.5s-19.0s), PC 21.0s (14.0s-23.5s), or CC 17.0s (13.5s-27.5s). For T2, there was also no significant (P = .25) differences among UP 24.0s (17.5s-27.0s), PC 26.0s (21.0s-32.0s), or CC 24.0s (19.5s-33.5s). Conclusion: There were no statistically significant differences in time to balloon inflation or ventilation. Higher levels of PPE do not appear to increase time to ETI.

scholarly journals Predictive value of clinical toxicities of chemotherapy with fluoropyrimidines and oxaliplatin in colorectal cancer by DPYD and GSTP1 gene polymorphisms

2020 ◽  
Author(s):  
Xunwei Deng ◽  
Jingyuan Hou ◽  
Qiaoting Deng ◽  
Zhixiong Zhong
Keyword(s):  
Colorectal Cancer ◽  
Adverse Events ◽  
Direct Sequencing ◽  
Dihydropyrimidine Dehydrogenase ◽  
Severe Toxicity ◽  
Nucleotide Polymorphisms ◽  
Mutant Type ◽  
Severe Vomiting ◽  
Significant Difference ◽  
The Impact

Abstract Background: Fluoropyrimidines and platinum are still widely used for colorectal cancer (CRC) management. Several studies have reported that mutations of dihydropyrimidine dehydrogenase (DPYD) and glutathione S-transferase pi-1 (GSTP1) polymorphisms are related to Chemotherapy-related adverse events. In the present study, we purposed to assess the impact of DPYD and GSTP1 variants on the toxicity of adjuvant chemotherapy risk among the Hakka population, minimize adverse events, and to maximize therapy outcome for individualized treatment.Methods: Genotyping was examined in 104 patients diagnosed with CRC cases and receiving fluoropyrimidine and platinum drugs based chemotherapy regimen by direct sequencing of DPYD and GSTP1 polymorphisms. Three DPYD variants including *2A, *5A, *9A, and GSTP1 c.313A>G were analyzed and clinical outcomes were assessed.Results: The data suggest that the incidence of DPYD*5A, DPYD*9A, and GSTP1 c.313A>G variants were 38.4%, 24%, and 32.7%, respectively. DPYD*2A variant was not found. A total of 23 patients (22.1%) suffered severe vomiting and 19 patients (18.3%) suffered severe anemia. DPYD*5A polymorphism was found significantly associated with grade 3/4 ulceration (p = 0.001). GSTP1 was determined to be an independent risk factor for severe vomiting and skin ulceration (p = 0.042 and p = 0.018, respectively). Patients with GSTP1 c. 313A>G mutant type contributed to a higher risk for grade severe toxicity compared with wild genotype (p = 0.027). Nevertheless, no significant difference was found between patients with DPYD*2A, *5A, *9A for chemotherapeutic toxicity.Conclusions: The results demonstrated that GSTP1 polymorphisms were useful predictors of severe events. Screening of single nucleotide polymorphisms of GSTP1 in colorectal cancer patients before chemotherapy may help to realize personalized therapy.

Impact of pharmacists in mental health over the past decade

2012 ◽  
Vol 1 (10) ◽  
pp. 252-260 ◽  
Author(s):  
Jennifer E. Thomas ◽  
Joshua Caballero
Keyword(s):  
Health Care Providers ◽  
Case Reports ◽  
Case Series ◽  
Cost Savings ◽  
Interdisciplinary Approach ◽  
Controlled Trials ◽  
Care Providers ◽  
The Past ◽  
Significant Difference ◽  
The Impact

Purpose: As healthcare moves towards an interdisciplinary approach to improve clinical outcomes, it has become increasingly important for health care providers to collaboratively work together. Pharmacists have been working with psychiatrists for several decades to improve patient outcomes. However, their utility in psychiatry has not been recently elucidated. The purpose of this article is to describe and evaluate the impact of pharmacists in psychiatric settings over the past ten years. Methods: A literature search was conducted using PubMed and CINAHL Plus with Full Text. Studies published between 2002 and 2011 were included. Additional studies were identified through references contained within the studies. Case reports and case series were excluded. Results: Seventeen studies met the inclusion criteria: 15 studies in outpatient settings, two in inpatient settings. Outcomes measured included: patient symptoms, economic outcomes, medication adherence, and patient satisfaction. The majority of studies found improvements (e.g., resolution of symptoms, cost savings). However, controlled trials found no significant difference in clinical improvement from pharmacists' interventions. Conclusion: Although the majority of studies suggest pharmacists provide positive outcomes, the trials vary widely in quality and measured outcomes. Additional controlled trials with more standardized methods are recommended to support the role of pharmacists in psychiatric settings.

Manageable Side Effects of Intravenous Iron in a Community Practice

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 4687-4687
Author(s):  
Nicole Brown ◽  
David H. Henry ◽  
Patricia A. Ford
Keyword(s):  
Side Effects ◽  
Adverse Events ◽  
Health Care Providers ◽  
Iron Sucrose ◽  
Iron Dextran ◽  
Care Providers ◽  
Stomach Pain ◽  
Significant Difference ◽  
Iv Iron ◽  
Hands And Feet

Abstract Our community hematology oncology practice uses intravenous (IV) iron in a wide variety of patients. A review of the literature on the adverse events (AE) of IV iron found 0.0–32.0% of patients were experiencing an AE with 0.0–0.5 events per patient. In our experience with IV iron, we felt that the actual incidence of AE was much higher than reported. Between June 2006 and April 2007, 156 patient surveys were completed by a total of 120 patients. Surveys were given to patients who had received IV iron in the past week. Those who experience adverse events were asked to note the type, onset, duration and intervention used to alleviate symptoms. Six patients were excluded for reporting symptoms occurring prior to treatment or completing the survey immediately after IV iron treatment. Of the remaining patients, 100 were female and 14 were male with an average age of 48.9 years (17–95 years). Eighty-six patients received iron sucrose, 22 sodium ferric gluconate and 6 iron dextran (InFed). In our patients, 48.2% experienced at least one AE with an average of 1.3 symptoms per patient (see table). The majority of these events (94.5%) were delayed and mild or moderate with only 5.5% of patients requiring a visit to the hospital or physician’s office. Common side effects were muscle or bone aches, dizziness, numbness, tingling and swelling of the hands and feet, abdominal pain and nausea/vomitting. There was no statistically significant difference in the number or severity of AE related to the different preparations. In our experience, AE occur at an increased frequency compared to the published literature. We feel it is important for health care providers to be aware that AE are likely to occur, but that they are usually minor and quite manageable without the need for physician intervention. In our practice the nurses trained in chemotherapy are well equipped to handle most events that arise. We find IV iron to be an extremely useful treatment for patients suffering from both absolute and functional iron deficiency and offer this data as evidence that parenteral iron is safe in a wide variety of patients. Comparison of AE Iron Sucrose n=86 Sodium Ferric Gluconate n=22 Iron Dextran n=6 Our Study n=114 Previously Reported Muscle or bone aches 17.4% 22.7% 50.0% 20.2% 0.0–3.8% Dizzy/Lightheadedness 16.3% 22.7% 33.3% 18.4% 0.0–0.9% Numbness/Tingling in hands/feet 14.0% 9.1% 16.7% 13.2% N/A Swelling in hands/feet 12.8% 13.6% 16.7% 13.2% 0.0–12.9% Stomach pain/cramping 10.5% 18.2% 16.7% 12.3% 0.0–4.5% Nausea/vomiting 10.5% 13.6% 16.7% 11.4% 0.0–25% Itching 10.5% 4.5% 16.7% 9.6% 0.0–1.5% Chest tightness/discomfort 4.7% 9.1% 0.0% 5.3% 0.0–1.0% Shortness of breath 3.5% 13.6% 0.0% 5.3% 0.0–1.5% Facial Flushing 3.5% 0.0% 0.0% 2.6% 0.0–.3% Hives 1.2% 4.5% 0.0% 1.8% 0.0–6.45% Other 12.8% 13.6% 50.0% 14.9% 0.0–30.0% Any symptom 44.2% 59.1% 66.7% 48.2% 0.0–32.26% Total symptoms 1.2 symptoms/patient 1.5 symptoms/patient 2.2 symptoms/patient 1.3 symptoms/patient 0.0–.45 symptoms/patient

The impact of genetic variability on severe toxicity of (neo-) adjuvant chemotherapy in breast cancer patients receiving 5-fluorouracil, epirubicin, and cyclofosfamide (FEC).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 1020-1020
Author(s):  
Christof Vulsteke ◽  
Diether Lambrechts ◽  
Anne-Sophie Dieudonné ◽  
Sigrid Hatse ◽  
Barbara Brouwers ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Genetic Variability ◽  
Febrile Neutropenia ◽  
Adverse Events ◽  
Multi Drug Resistance ◽  
Hematological Toxicity ◽  
Severe Toxicity ◽  
Wild Type ◽  
Grade 3 ◽  
The Impact

1020 Background: We assessed the impact of single nucleotide polymorphisms (SNP) of potential genes of interest in germline DNA on severe adverse events in breast cancer (bc) patients receiving (neo-) adjuvant FEC chemotherapy. Methods: Cases were retrospectively evaluated through electronic chart review for febrile neutropenia (primary endpoint), febrile neutropenia first cycle, prolonged grade 4 or deep (<100/µl) neutropenia, anemia grade 3-4, thrombocytopenia grade 3-4 and non-hematological grade 3-4 events. The panel of genes, genotyped using iPLEX technology on a MALDI-TOF based MassARRAY Compact Analyser (Sequenom Inc., CA, USA), included ABCBI, ABCC1, ABCC2, ABCG2, ALDH3A1, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, CYP3A5, DPYD, FGFR4, GPX4, GSTA1, GSTP1, MTHFR, NQ01, TYMS, XPD/ERCC2, XRCC1, UGT1A1, UGT1A6 and UGT2B7. These genes are involved in the metabolization of the studied chemotherapeutics. Because of multiple testing the false discovery rate (FDR) was calculated. Results: We identified 1089 patients treated between 2000-2010 with 3-6 cycles of FEC, for whom germline DNA was available.Homozygous (TT, 0.5%) and heterozygous (GT,11%) genotypes for rs4148350 in the Multi Drug Resistance Protein I (ABCC1/MRP1), compared to wild-type (GG, 88.5%), were associated with febrile neutropenia, febrile neutropenia in first cycle, prolonged grade 4 or deep neutropenia and thrombocytopenia (80 vs 25 vs 15.7%, 40 vs 17.6 vs 9.5%, 100 vs 41.7 vs 33.8% and 20 vs 2.8 vs 0.34% respectively; p 0.0006, 0.01, 0.002 and 0.008 FDR 0.03, 0.65, 0.06 and 0.2). Variant genotypes for rs45511401 (GT/TT, 12%) in ABCC1, compared to wild-type (GG, 88%), were associated with febrile neutropenia, febrile neutropenia in first cycle and thrombocytopenia (26.5 vs 15,8%, 17.1 vs 9.7% and 3.4 vs 0.3%, respectively; p 0.007, 0.03 and 0.005, FDR 0.2, 0.75 and 0.2). Conclusions: Genetic variation in the ABCC1 gene was strongly associated with severe hematological toxicity of FEC. Other previously described SNP were not validated. This is the largest bc study in which the impact of genetic variability on the adverse events of FEC chemotherapy was investigated.

scholarly journals Effectiveness of an Electronic Communication Tool on Transitions in Care From the Intensive Care Unit: Protocol for a Cluster-Specific Pre-Post Trial

10.2196/18675 ◽  
2021 ◽  
Vol 10 (1) ◽  
pp. e18675
Author(s):  
Jeanna Parsons Leigh ◽  
Rebecca Brundin-Mather ◽  
Liam Whalen-Browne ◽  
Devika Kashyap ◽  
Khara Sauro ◽  
...  
Keyword(s):  
Health Care ◽  
Intensive Care ◽  
Health Care Providers ◽  
Primary Outcome ◽  
Audit And Feedback ◽  
Free Text ◽  
Care Providers ◽  
Transitions In Care ◽  
Post Trial ◽  
The Impact

Background Transitions in care are vulnerable periods in health care that can expose patients to preventable errors due to incomplete or delayed communication between health care providers. Transitioning critically ill patients from intensive care units (ICUs) to other patient care units (PCUs) is particularly risky, due to the high acuity of the patients and the diversity of health care providers involved in their care. Instituting structured documentation to standardize written communication between health care providers during transitions has been identified as a promising means to reduce communication breakdowns. We developed an evidence-informed, computer-enabled, ICU-specific structured tool—an electronic transfer (e-transfer) tool—to facilitate and standardize the composition of written transfer summaries in the ICUs of one Canadian city. The tool consisted of 10 primary sections with a user interface combination of structured, automated, and free-text fields. Objective Our overarching goal is to evaluate whether implementation of our e-transfer tool will improve the completeness and timeliness of transfer summaries and streamline communications between health care providers during high-risk transitions. Methods This study is a cluster-specific pre-post trial, with randomized and staggered implementation of the e-transfer tool in four hospitals in Calgary, Alberta. Hospitals (ie, clusters) were allocated randomly to cross over every 2 months from control (ie, dictation only) to intervention (ie, e-transfer tool). Implementation at each site was facilitated with user education, point-of-care support, and audit and feedback. We will compare transfer summaries randomly sampled over 6 months postimplementation to summaries randomly sampled over 6 months preimplementation. The primary outcome will be a binary composite measure of the timeliness and completeness of transfer summaries. Secondary measures will include overall completeness, timeliness, and provider ratings of transfer summaries; hospital and ICU lengths of stay; and post-ICU patient outcomes, including ICU readmission, adverse events, cardiac arrest, rapid response team activation, and mortality. We will use descriptive statistics (ie, medians and means) to describe demographic characteristics. The primary outcome will be compared within each hospital pre- and postimplementation using separate logistic regression models for each hospital, with adjustment for patient characteristics. Results Participating hospitals were cluster randomized to the intervention between July 2018 and January 2019. Preliminary extraction of ICU patient admission lists was completed in September 2019. We anticipate that evaluation data collection will be completed by early 2021, with first results ready for publication in spring or summer 2021. Conclusions This study will report the impact of implementing an evidence-informed, computer-enabled, ICU-specific structured transfer tool on communication and preventable medical errors among patients transferred from the ICU to other hospital care units. Trial Registration ClinicalTrials.gov NCT03590002; https://www.clinicaltrials.gov/ct2/show/NCT03590002 International Registered Report Identifier (IRRID) DERR1-10.2196/18675

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