Purpose During the COVID-19 pandemic, pediatric nurses at one medical center in New York assumed ... more Purpose During the COVID-19 pandemic, pediatric nurses at one medical center in New York assumed care of COVID-19 adult patients. The purpose of this study was to understand pediatric nurses' experiences during the peak of the COVID-19 pandemic, when they were caring for patients outside of their usual practice. Design and methods A qualitative descriptive study was implemented, and a descriptive survey was sent to all pediatric nurses who worked during the peak of the pandemic, from March 2020 – May 2020. Categorical responses were analyzed using descriptive statistics and free texts were coded to develop central themes. Results Four themes emerged from the data: concerns for safety, unprepared to care, nurses' emotional responses, and persevering together. Conclusions As pediatric nurses adjusted to caring for a new disease and a new population of patients, concerns of safety and preparedness emanated. The need for teamwork and support was emphasized by nurses. The impact that nurses' experiences had on their emotional wellbeing was also highlighted. Practice implications Exploring pediatric nurses' experiences during a pandemic is important, as it furthers understanding and guides efforts to enhance preparedness for a future pandemic or public health emergency. Findings from this study illustrate the need to provide nurses with support for both their physical and emotional health.
American Journal of Clinical Oncology, Oct 1, 2002
The purpose of this study was to determine the safety of irinotecan and capecitabine in patients ... more The purpose of this study was to determine the safety of irinotecan and capecitabine in patients with advanced solid tumors. Thirty-four patients received 122 courses of irinotecan 200 to 300 mg/m(2) as an intravenous infusion during 30 minutes on day 1 and capecitabine 1,500 to 3,000 mg/d orally 12 hours apart starting on day 2 for 14 days, repeated every 21 days (one course). Three to seven patients were treated in six dose-escalation cohorts. Three of 7 (43%) patients treated with irinotecan 300 mg/m(2) and capecitabine 2,300 mg/d had course 1 dose-limiting toxicity (DLT) defining maximum tolerated dosage (MTD). Fatigue and diarrhea were the major DLTs, and other events included neutropenia, anorexia, and hand-foot syndrome. At one dose level below the MTD, none of 7 patients treated with irinotecan 275 mg/m(2), and capecitabine 2,300 mg/d (36 courses) had course 1 DLT. Grade III to IV toxicities beyond course 1 included neutropenia (11% of all courses), fatigue (3.4%) and hand-foot syndrome (3.4%). There were only two episodes of febrile grade II neutropenia. There were no toxic deaths. Transient antitumor response was noted in one patient with irinotecan and 5-fluorouracil-refractory colon cancer. The combination of irinotecan 275 mg/m(2) and capecitabine 2,300 mg/d represents a safe, favorable, and convenient outpatient regimen warranting further phase II evaluation.
To develop a combination of pegylated liposomal doxorubicin (Doxil; Alza Pharmaceuticals, Palo Al... more To develop a combination of pegylated liposomal doxorubicin (Doxil; Alza Pharmaceuticals, Palo Alto, CA) and docetaxel (Taxotere; Aventis Pharmaceutical, Parsipanny, NJ) that can be safely used for the treatment of advanced breast cancer. Forty-one patients with locally advanced (n = 10) or metastatic (n = 31) breast cancer received Doxil (30-, 40-, or 45-mg/m(2) intravenous [IV] infusion over 30 to 60 minutes), followed 1 hour later by docetaxel (60 or 75 mg/m(2) by IV infusion over 1 hour) in cohorts of three to six patients. Dose-limiting toxicity (DLT) was defined as febrile neutropenia, prolonged neutropenia, or grade 3 to 4 nonhematologic toxicity that occurred during cycle 1. In conjunction with docetaxel 75 mg/m(2) every 4 weeks, the MTD of Doxil was 30 mg/m(2) and required granulocyte colony-stimulating factor (G-CSF) to prevent febrile neutropenia. Without G-CSF, the MTD was docetaxel 60 mg/m(2) and Doxil 30 mg/m(2) every 3 weeks; only 1 (7%) out of 15 patients treated at this dose level had cycle 1 DLT. Infusion reactions were common with Doxil with the recommended infusion schedule during the first cycle (55%) but were reduced with a modified schedule (7%). There was no clinically significant cardiac toxicity. Objective response occurred in eight of nine assessable patients with stage III disease and in 16 (52%) of 31 patients (95% confidence interval, 34% to 70%) with stage IV disease. The recommended dose and schedule of this combination for further evaluation is Doxil 30 mg/m(2) and docetaxel 60 mg/m(2) given every 3 weeks without G-CSF. When used with G-CSF, it is Doxil 30 mg/m(2) and docetaxel 75 mg/m(2) every 4 weeks.
676 Background: Tipifarnib is an orally administered farnesyltransferase inhibitor (FTI) that is ... more 676 Background: Tipifarnib is an orally administered farnesyltransferase inhibitor (FTI) that is active in metastatic breast cancer (J Clin Oncol 21; 2492-2499, 2003). The purpose of this phase I trial was to determine the feasability of combining tipifarnib with doxorubicin and cyclophosphamide in patients with metastatic breast cancer (MBC); the intent was to identify a suitable regimen for subsequent study in locally advanced breast cancer (LABC). METHODS Eligible patients with MBC received tipifarnib plus standard AC chemotherapy (doxorubicin [60 mg/m2] and cyclophosphamide [600 mg/m2]) given every 3 weeks, or every 2 weeks in conjunction with granulocyte-colony stimulating factor (G-CSF), in cohorts of 3-6 patients per dose level. Dose-limiting toxicty (DLT) was defined as cycle 1 grade 3-4 febrile neutropenia, thrombocytopenia, or non-hematologic toxicity. Patients received a maximum of 4 cycles of therapy. RESULTS After accrual of 2 patients to the every 3 week schedule without G-CSF, the protocol was modified to a 2 week schedule with G-CSF because of evidence for a superior outcome for dose-dense therapy in operable breast cancer (J Clin Oncol 21: 1431-1439, 2003). The recommended phase II dose (RPTD) of tipifarnib was 200 mg BID on days 1-7 when combined with AC plus G-CSF given every 2 weeks. Febrile neutropenia was dose-limiting at 300 mg BID for 7 days. Objective response occurred in 8 of 9 evaluable patients. CONCLUSIONS The RPTD of tipifarnib is 200 mg PO BID for 7 days on days 1-7 when given with standard dose-dense AC plus G-CSF. This regimen is now being evaluated in patients with LABC. [Figure: see text] [Table: see text].
e16798 Background: There are no accepted guidelines for testing individuals at elevated risk for ... more e16798 Background: There are no accepted guidelines for testing individuals at elevated risk for developing pancreatic duct adenocarcinoma (PC). We initiated a prospective screening and surveillance program for individuals at elevated risk for PC. Methods: Eligibility for the Pancreatic Cancer Early Detection Protocol (PCEDP) was based on germ line status and/or family history of PC, provided that the imparted risk was either five times that of the general population or 7.5% lifetime risk for developing PC. Testing was continued alternating between Endoscopic Ultrasound (EUS) and Magnetic Resonance Imaging (MRI) of the abdomen. Objectives were was to analyze the number, type, and location of pancreatic conditions found and their associations with genetic or family history; and to evaluate the outcomes and/or complications that may have resulted from our testing. Results: From April 2014 through October 2019 we received 238 queries, out of which 75 individuals (31%) enrolled in the PCEDP. Eligibility was based upon individual’s germ line only (45%), family history only (32%), and both (23%). Germ line mutations were observed in 34 (BRCA2), 9 (BRCA1), 4 (ATM), 3 (PALB2), and 3 (CDKN2A) individuals. Median age at consent was 57, 60% were female,and88%, 4%, 3%, and 1% self-identified as Caucasian, African American, Hispanic, and Asian, respectively. 133 EUS procedures and 83 MRIs have been performed. No serious adverse events occurred. Standard Insurance approved and paid for the vast majority of tests. Four individuals withdrew (5%) and three (4%) were lost to follow up. Ten individuals (13%) were found to have abnormal findings in the pancreas and therefore met an endpoint of the study, including seven anechoic cysts and three suspected intraductal papillary mucinous neoplasms (IPMN). All individuals with endpoints were recommended to continue surveillance with EUS. Eight of the ten endpoints were found on baseline EUS, one one from baseline MRI, and one was found on the 3rd EUS. One of the individuals with a 2.5cm IPMN seen on baseline EUS underwent a subsequent distal pancreatectomy, with pathology revealing high grade dysplasia. Conclusions: Screening and surveillance for PC using EUS alternating with MRI was feasible and well tolerated in our population of individuals with an elevated risk. Baseline EUS was successful in detecting 10/75 = 13% of enrollees with some abnormal pancreatic finding, including one requiring intervention with a high grade pre-malignant IPMN.
Delegation by the registered nurse is a decision making process that includes assessment, plannin... more Delegation by the registered nurse is a decision making process that includes assessment, planning, implementation, and evaluation. Due to an ever-expanding global shortage of nurses, registered nurses are increasingly dependent on unlicensed assistive personnel to assist in the provision of safe patient care. Delegation is recognised as a fundamental nursing skill that can be utilised effectively to improve quality care. To examine and synthesize the best available evidence regarding the impact of delegation interventions used by the registered nurse with the unlicensed assistive personnel and their impact on quality of care, patient satisfaction, and registered nurse staff satisfaction. Registered nurses and unlicensed assistive personnel in patient care settings where delegation occurs.This review considered studies that evaluated the effectiveness of delegation interventions by registered nurses to unlicensed assistive personnel.The outcomes examined were quality of care, patien...
Purpose During the COVID-19 pandemic, pediatric nurses at one medical center in New York assumed ... more Purpose During the COVID-19 pandemic, pediatric nurses at one medical center in New York assumed care of COVID-19 adult patients. The purpose of this study was to understand pediatric nurses' experiences during the peak of the COVID-19 pandemic, when they were caring for patients outside of their usual practice. Design and methods A qualitative descriptive study was implemented, and a descriptive survey was sent to all pediatric nurses who worked during the peak of the pandemic, from March 2020 – May 2020. Categorical responses were analyzed using descriptive statistics and free texts were coded to develop central themes. Results Four themes emerged from the data: concerns for safety, unprepared to care, nurses' emotional responses, and persevering together. Conclusions As pediatric nurses adjusted to caring for a new disease and a new population of patients, concerns of safety and preparedness emanated. The need for teamwork and support was emphasized by nurses. The impact that nurses' experiences had on their emotional wellbeing was also highlighted. Practice implications Exploring pediatric nurses' experiences during a pandemic is important, as it furthers understanding and guides efforts to enhance preparedness for a future pandemic or public health emergency. Findings from this study illustrate the need to provide nurses with support for both their physical and emotional health.
American Journal of Clinical Oncology, Oct 1, 2002
The purpose of this study was to determine the safety of irinotecan and capecitabine in patients ... more The purpose of this study was to determine the safety of irinotecan and capecitabine in patients with advanced solid tumors. Thirty-four patients received 122 courses of irinotecan 200 to 300 mg/m(2) as an intravenous infusion during 30 minutes on day 1 and capecitabine 1,500 to 3,000 mg/d orally 12 hours apart starting on day 2 for 14 days, repeated every 21 days (one course). Three to seven patients were treated in six dose-escalation cohorts. Three of 7 (43%) patients treated with irinotecan 300 mg/m(2) and capecitabine 2,300 mg/d had course 1 dose-limiting toxicity (DLT) defining maximum tolerated dosage (MTD). Fatigue and diarrhea were the major DLTs, and other events included neutropenia, anorexia, and hand-foot syndrome. At one dose level below the MTD, none of 7 patients treated with irinotecan 275 mg/m(2), and capecitabine 2,300 mg/d (36 courses) had course 1 DLT. Grade III to IV toxicities beyond course 1 included neutropenia (11% of all courses), fatigue (3.4%) and hand-foot syndrome (3.4%). There were only two episodes of febrile grade II neutropenia. There were no toxic deaths. Transient antitumor response was noted in one patient with irinotecan and 5-fluorouracil-refractory colon cancer. The combination of irinotecan 275 mg/m(2) and capecitabine 2,300 mg/d represents a safe, favorable, and convenient outpatient regimen warranting further phase II evaluation.
To develop a combination of pegylated liposomal doxorubicin (Doxil; Alza Pharmaceuticals, Palo Al... more To develop a combination of pegylated liposomal doxorubicin (Doxil; Alza Pharmaceuticals, Palo Alto, CA) and docetaxel (Taxotere; Aventis Pharmaceutical, Parsipanny, NJ) that can be safely used for the treatment of advanced breast cancer. Forty-one patients with locally advanced (n = 10) or metastatic (n = 31) breast cancer received Doxil (30-, 40-, or 45-mg/m(2) intravenous [IV] infusion over 30 to 60 minutes), followed 1 hour later by docetaxel (60 or 75 mg/m(2) by IV infusion over 1 hour) in cohorts of three to six patients. Dose-limiting toxicity (DLT) was defined as febrile neutropenia, prolonged neutropenia, or grade 3 to 4 nonhematologic toxicity that occurred during cycle 1. In conjunction with docetaxel 75 mg/m(2) every 4 weeks, the MTD of Doxil was 30 mg/m(2) and required granulocyte colony-stimulating factor (G-CSF) to prevent febrile neutropenia. Without G-CSF, the MTD was docetaxel 60 mg/m(2) and Doxil 30 mg/m(2) every 3 weeks; only 1 (7%) out of 15 patients treated at this dose level had cycle 1 DLT. Infusion reactions were common with Doxil with the recommended infusion schedule during the first cycle (55%) but were reduced with a modified schedule (7%). There was no clinically significant cardiac toxicity. Objective response occurred in eight of nine assessable patients with stage III disease and in 16 (52%) of 31 patients (95% confidence interval, 34% to 70%) with stage IV disease. The recommended dose and schedule of this combination for further evaluation is Doxil 30 mg/m(2) and docetaxel 60 mg/m(2) given every 3 weeks without G-CSF. When used with G-CSF, it is Doxil 30 mg/m(2) and docetaxel 75 mg/m(2) every 4 weeks.
676 Background: Tipifarnib is an orally administered farnesyltransferase inhibitor (FTI) that is ... more 676 Background: Tipifarnib is an orally administered farnesyltransferase inhibitor (FTI) that is active in metastatic breast cancer (J Clin Oncol 21; 2492-2499, 2003). The purpose of this phase I trial was to determine the feasability of combining tipifarnib with doxorubicin and cyclophosphamide in patients with metastatic breast cancer (MBC); the intent was to identify a suitable regimen for subsequent study in locally advanced breast cancer (LABC). METHODS Eligible patients with MBC received tipifarnib plus standard AC chemotherapy (doxorubicin [60 mg/m2] and cyclophosphamide [600 mg/m2]) given every 3 weeks, or every 2 weeks in conjunction with granulocyte-colony stimulating factor (G-CSF), in cohorts of 3-6 patients per dose level. Dose-limiting toxicty (DLT) was defined as cycle 1 grade 3-4 febrile neutropenia, thrombocytopenia, or non-hematologic toxicity. Patients received a maximum of 4 cycles of therapy. RESULTS After accrual of 2 patients to the every 3 week schedule without G-CSF, the protocol was modified to a 2 week schedule with G-CSF because of evidence for a superior outcome for dose-dense therapy in operable breast cancer (J Clin Oncol 21: 1431-1439, 2003). The recommended phase II dose (RPTD) of tipifarnib was 200 mg BID on days 1-7 when combined with AC plus G-CSF given every 2 weeks. Febrile neutropenia was dose-limiting at 300 mg BID for 7 days. Objective response occurred in 8 of 9 evaluable patients. CONCLUSIONS The RPTD of tipifarnib is 200 mg PO BID for 7 days on days 1-7 when given with standard dose-dense AC plus G-CSF. This regimen is now being evaluated in patients with LABC. [Figure: see text] [Table: see text].
e16798 Background: There are no accepted guidelines for testing individuals at elevated risk for ... more e16798 Background: There are no accepted guidelines for testing individuals at elevated risk for developing pancreatic duct adenocarcinoma (PC). We initiated a prospective screening and surveillance program for individuals at elevated risk for PC. Methods: Eligibility for the Pancreatic Cancer Early Detection Protocol (PCEDP) was based on germ line status and/or family history of PC, provided that the imparted risk was either five times that of the general population or 7.5% lifetime risk for developing PC. Testing was continued alternating between Endoscopic Ultrasound (EUS) and Magnetic Resonance Imaging (MRI) of the abdomen. Objectives were was to analyze the number, type, and location of pancreatic conditions found and their associations with genetic or family history; and to evaluate the outcomes and/or complications that may have resulted from our testing. Results: From April 2014 through October 2019 we received 238 queries, out of which 75 individuals (31%) enrolled in the PCEDP. Eligibility was based upon individual’s germ line only (45%), family history only (32%), and both (23%). Germ line mutations were observed in 34 (BRCA2), 9 (BRCA1), 4 (ATM), 3 (PALB2), and 3 (CDKN2A) individuals. Median age at consent was 57, 60% were female,and88%, 4%, 3%, and 1% self-identified as Caucasian, African American, Hispanic, and Asian, respectively. 133 EUS procedures and 83 MRIs have been performed. No serious adverse events occurred. Standard Insurance approved and paid for the vast majority of tests. Four individuals withdrew (5%) and three (4%) were lost to follow up. Ten individuals (13%) were found to have abnormal findings in the pancreas and therefore met an endpoint of the study, including seven anechoic cysts and three suspected intraductal papillary mucinous neoplasms (IPMN). All individuals with endpoints were recommended to continue surveillance with EUS. Eight of the ten endpoints were found on baseline EUS, one one from baseline MRI, and one was found on the 3rd EUS. One of the individuals with a 2.5cm IPMN seen on baseline EUS underwent a subsequent distal pancreatectomy, with pathology revealing high grade dysplasia. Conclusions: Screening and surveillance for PC using EUS alternating with MRI was feasible and well tolerated in our population of individuals with an elevated risk. Baseline EUS was successful in detecting 10/75 = 13% of enrollees with some abnormal pancreatic finding, including one requiring intervention with a high grade pre-malignant IPMN.
Delegation by the registered nurse is a decision making process that includes assessment, plannin... more Delegation by the registered nurse is a decision making process that includes assessment, planning, implementation, and evaluation. Due to an ever-expanding global shortage of nurses, registered nurses are increasingly dependent on unlicensed assistive personnel to assist in the provision of safe patient care. Delegation is recognised as a fundamental nursing skill that can be utilised effectively to improve quality care. To examine and synthesize the best available evidence regarding the impact of delegation interventions used by the registered nurse with the unlicensed assistive personnel and their impact on quality of care, patient satisfaction, and registered nurse staff satisfaction. Registered nurses and unlicensed assistive personnel in patient care settings where delegation occurs.This review considered studies that evaluated the effectiveness of delegation interventions by registered nurses to unlicensed assistive personnel.The outcomes examined were quality of care, patien...
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