scholarly journals Effect of Pharmacists’ Interventions on the Appropriateness of Empiric Vancomycin Therapy in Oncology Patients with Febrile Neutropenia

2019 ◽  
Vol 26 (2) ◽  
pp. 53-59
Author(s):  
Nour Baghdady ◽  
Daniel Voit ◽  
Anne M. McDonell ◽  
David W. Kubiak
Keyword(s):  
Febrile Neutropenia ◽  
Phase I ◽  
Phase Ii ◽  
Vancomycin Therapy ◽  
Gram Positive ◽  
Oncology Patients ◽  
Two Phase ◽  
Pharmacy Intervention ◽  
Phase Study ◽  
Objective Evidence

The purpose of this observational study is to evaluate the effect of an active pharmacy intervention to facilitate timely discontinuation of empiric vancomycin therapy in oncology patients with febrile neutropenia who lack objective evidence of a Gram-positive infection. This was a two-phase study. Vancomycin use was evaluated retrospectively on all oncology patients with febrile neutropenia over four weeks (phase I). In a parallel four weeks a year later, vancomycin use in this patient population was evaluated prospectively (phase II). In the absence of evidence of Gram-positive infection after 72 hours of treatment initiation, the team was contacted by a pharmacist to encourage discontinuation. Usage was compared between both phases. Forty-three patients in phase I and 25 patients in phase II were treated with vancomycin with no evidence for Gram-positive infections. Pharmacists’ interventions were documented on 18 patients in phase II. Of these, 56% of interventions to discontinue vancomycin were accepted, but only 33.3% of patients had treatment stopped within 72 hours of initiation. Although not significant, a trend in more appropriate use of vancomycin in oncology patients with febrile neutropenia was observed. Pharmacist’s interventions might have played a role in this observation.

scholarly journals Nurses’ educational needs when dealing with aggression from patients and their families: a mixed-methods study

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e041711
Author(s):  
Kana Sato ◽  
Yoshimi Kodama
Keyword(s):  
Mixed Methods ◽  
Nursing Students ◽  
Phase I ◽  
Phase Ii ◽  
Mixed Methods Study ◽  
Self Awareness ◽  
Two Phase ◽  
Sequential Mixed Methods ◽  
Nursing Professionals ◽  
Educational Contents

ObjectivesTo explore the type of education needed for nurses when dealing with aggression from patients and their families.DesignA two-phase sequential mixed-methods study.SettingThis study was conducted in Japan, with phase I from March to November 2016 and phase II in November 2018.Main outcome measuresThe challenges faced by nurses when dealing with incidents of aggression from the neutral perspective of neither nurse nor patient/family and perceptions of the educational contents developed in this study. Descriptive analyses were used to examine the data retrieved from both phases.ParticipantsPhase I entailed semistructured interviews among 11 neutral-party participants who observed aggressive incidents between nurses and patients/families. Phase II consisted of a web survey conducted among 102 nursing students and 308 nursing professionals.ResultsPhase I resulted in the identification of the following five main educational components: understanding the mechanisms of anger and aggression, maintaining self-awareness, observant listening, managing the self-impression, and communicating based on specific disease characteristics. Each component was related to improved communication through self-awareness. The results of phase II indicated that participants positively perceived these educational contents as likely to be effective for dealing with aggression from patients/families.ConclusionsThis study clarified the type of education needed for nurses when dealing with aggression based on multiple viewpoints. Specifically, neutral-party interviews revealed that communication should be improved through self-awareness. A subsequent survey among nurses and nursing students showed that the identified educational contents were positively received.

scholarly journals Mixed methods study protocol to examine perceptions of family medicine among long-term patients of a family medicine clinic in Japan

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e037113
Author(s):  
Kotaro Sato ◽  
Ryoko Michinobu ◽  
Tesshu Kusaba
Keyword(s):  
Primary Care ◽  
Mixed Methods ◽  
Family Medicine ◽  
Phase I ◽  
Phase Ii ◽  
Medical Specialty ◽  
Structured Interviews ◽  
Two Phase ◽  
Care Systems

IntroductionFamily physicians or general practitioners play central roles in many countries’ primary care systems, but family medicine (FM) remains relatively unestablished in Japan. Previous studies in Japan have examined the general population’s understanding of FM as a medical specialty, but none have explored this topic using actual FM clinic patients. Here, we describe a protocol to explore the perceptions of FM among long-term patients of one of Japan’s oldest FM clinics.Methods and analysisThe study will be conducted at the Motowanishi Family Clinic in Hokkaido, Japan, using patients who have attended the clinic for over 10 years. The analysis will adopt a two-phase explanatory sequential mixed methods design. During phase I, quantitative data from participants’ medical records will be collected and reviewed, and patients’ perceptions of FM will be assessed through a questionnaire. The correlations between participants’ knowledge that the clinic specialises in FM and various characteristics will be examined. In phase II, qualitative data will be collected through semi-structured interviews of approximately 10 participants selected using maximum variation sampling based on phase I results. A thematic analysis will be conducted in phase II to identify patients’ perceptions and changes in perceptions. Finally, each theme identified in phase II will be transformed into a quantitative variable to analyse the relationships between the phases. A joint display will be used to integrate the phases’ findings and examine how phase II results explain phase I results.Ethics and disseminationThe institutional review board of the Japan Primary Care Association has approved this research (2019-003). The results will be presented at the association’s annual academic meeting and submitted for publication in relevant journals. The findings will also be provided to the patients via the clinic’s internal newsletter.

scholarly journals COVID-19 and radiation oncology: the experience of a two-phase plan within a single institution in central Italy

2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Luciana Caravatta ◽  
Consuelo Rosa ◽  
Maria Bernadette Di Sciascio ◽  
Andrea Tavella Scaringi ◽  
Angelo Di Pilla ◽  
...  
Keyword(s):  
Phase I ◽  
Phase Ii ◽  
Central Italy ◽  
Significant Risk ◽  
Tumor Board ◽  
Radiotherapy Planning ◽  
Two Phase ◽  
Hospital Environments ◽  
Two Phases

Abstract Background COVID-19 in Italy has led to the need to reorganize hospital protocols with a significant risk of interruption to cancer treatment programs. In this report, we will focus on a management model covering the two phases of the COVID-19 emergency, namely lockdown-phase I and post-lockdown-phase II. Methods The following steps were taken in the two phases: workload during visits and radiotherapy planning, use of dedicated routes, measures for triage areas, management of suspected and positive COVID-19 cases, personal protective equipment, hospital environments and intra-institutional meetings and tumor board management. Due to the guidelines set out by the Ministry of Health, oncological follow-up visits were interrupted during the lockdown-phase I; consequently, we set about contacting patients by telephone, with laboratory and instrumental exams being viewed via telematics. During the post-lockdown-phase II, the oncological follow-up clinic reopened, with two shifts operating daily. Results By comparing our radiotherapy activity from March 9 to May 4 2019 with the same period in 2020 during full phase I of the COVID-19 emergency, similar results were achieved. First radiotherapy visits, Simulation Computed Tomography and Linear Accelerator treatments amounted to 123, 137 and 151 in 2019 compared with 121, 135 and 170 in 2020 respectively. There were no cases of COVID-19 positivity recorded either in patients or in healthcare professionals, who were all negative to the swab tests performed. Conclusion During both phases of the COVID-19 emergency, the planned model used in our own experience guaranteed both continuity in radiotherapy treatments whilst neither reducing workload nor interrupting treatment and, as such, it ensured the safety of cancer patients, hospital environments and staff.

Combination of Oxaliplatin Plus Irinotecan in Patients With Gastrointestinal Tumors: Results of Two Independent Phase I Studies With Pharmacokinetics

1999 ◽  
Vol 17 (6) ◽  
pp. 1751-1751 ◽  
Author(s):  
Ernesto Wasserman ◽  
Caroline Cuvier ◽  
François Lokiec ◽  
François Goldwasser ◽  
Salima Kalla ◽  
...  
Keyword(s):  
Phase I ◽  
Phase Ii ◽  
Performance Status ◽  
Maximum Tolerated Dose ◽  
Two Phase ◽  
Phase I Studies ◽  
Phase Ii Studies ◽  
Minute Period ◽  
Grade 3 ◽  
Febrile Episodes

PURPOSE: Two phase I studies of the oxaliplatin and irinotecan combination were performed in advanced gastrointestinal cancer patients to characterize the safety and pharmacokinetics of the regimen. PATIENTS AND METHODS: Patients with a performance status (PS) of ≤2 and normal hematologic, hepatic, and renal functions received oxaliplatin (2-hour intravenous infusion) followed 1 hour later by irinotecan administered over a 30-minute period, every 3 weeks. Dose levels that were explored ranged from 85 to 110 mg/m2 for oxaliplatin and 150 to 250 mg/m2 for irinotecan. Plasma pharmacokinetics of total and ultrafiltrable platinum, irinotecan, SN-38, and its glucuronide, SN-38G, were determined. RESULTS: Thirty-nine patients with gastrointestinal carcinomas (24 with colorectal cancer [CRC], four with pancreas cancer, four with gastric cancer, three with hepatocarcinoma, and four with other) received 216 treatment cycles. Median age was 54 years (range, 21 to 72 years); 95% had PS of 0 to 1; all but six had failed fluorouracil (5-FU) chemotherapy. The maximum-tolerated dose was oxaliplatin 110 mg/m2 plus irinotecan 200 mg/m2 in one study and oxaliplatin 110 mg/m2 plus irinotecan 250 mg/m2 in the other study. Grade 3 to 4 diarrhea and febrile neutropenia were dose-limiting toxicities; other toxicities included emesis and dose-cumulative neuropathy. Recommended dose for phase II studies is oxaliplatin 85 mg/m2 and irinotecan 200 mg/m2. At this dose (12 patients, 65 cycles), grade 3 and 4 toxicities per patient included the following: emesis in 42% of patients, neutropenia in 33% (febrile episodes in 17%), peripheral neuropathy in 25%, delayed diarrhea in 17%, and thrombocytopenia in 8%. Two patients with Gilbert's syndrome experienced severe irinotecan toxicity. No plasmatic pharmacokinetic interactions were detected. Seven partial responses were observed in 24 CRC patients. CONCLUSION: This combination is feasible, with activity in 5-FU–resistant CRC patients. Phase I studies that explore the every-2-weeks schedule, in addition to phase II studies of this schedule (as well as in combination with 5-FU) as second-line therapy of metastatic CRC, are ongoing.

scholarly journals Augmented pseudo-likelihood estimation for two-phase studies

2019 ◽  
Vol 29 (2) ◽  
pp. 344-358
Author(s):  
Claudia Rivera-Rodriguez ◽  
Sebastien Haneuse ◽  
Molin Wang ◽  
Donna Spiegelman
Keyword(s):  
Phase I ◽  
Phase Ii ◽  
Likelihood Estimation ◽  
Weighted Likelihood ◽  
Finite Sample ◽  
Cross Sectional Survey ◽  
Two Phase ◽  
Cross Sectional ◽  
Pseudo Likelihood ◽  
Pseudo Likelihood Estimation

In many public health and medical research settings, information on key covariates may not be readily available or too expensive to gather for all individuals in the study. In such settings, the two-phase design provides a way forward by first stratifying an initial (large) phase I sample on the basis of covariates readily available (including, possibly, the outcome), and sub-sampling participants at phase II to collect the expensive measure(s). When the outcome of interest is binary, several methods have been proposed for estimation and inference for the parameters of a logistic regression model, including weighted likelihood, pseudo-likelihood and maximum likelihood. Although these methods yield consistent estimation and valid inference, they do so solely on the basis of the phase I stratification and the detailed covariate information obtained at phase II. Moreover, they ignore any additional information that is readily available at phase I but was not used as part of the stratified sampling design. Motivated by the potential for efficiency gains, especially concerning parameters corresponding to the additional phase I covariates, we propose a novel augmented pseudo-likelihood estimator for two-phase studies that makes use of all available information. In contrast to recently-proposed weighted likelihood-based methods that calibrate to the influence function of the model of interest, the methods we propose do not require the development of additional models and, therefore, enjoy a degree of robustness. In addition, we expand the broader framework for pseudo-likelihood based estimation and inference to permit link functions for binary regression other than the logit link. Comprehensive simulations, based on a one-time cross sectional survey of 82,887 patients undergoing anti-retroviral therapy in Malawi between 2005 and 2007, illustrate finite sample properties of the proposed methods and compare their performance competing approaches. The proposed method yields the lowest standard errors when the model is correctly specified. Finally, the methods are applied to a large implementation science project examining the effect of an enhanced community health worker program to improve adherence to WHO guidelines for at least four antenatal visits, in Dar es Salaam, Tanzania.

scholarly journals ‘I actually felt like I was a researcher myself.’ On involving children in the analysis of qualitative paediatric research in the Netherlands

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e034433
Author(s):  
Malou L Luchtenberg ◽  
Els L M Maeckelberghe ◽  
AA Eduard Verhagen
Keyword(s):  
The Netherlands ◽  
Phase I ◽  
Phase Ii ◽  
Qualitative Data ◽  
Paediatric Research ◽  
Two Phase ◽  
New Approach ◽  
Time Investment ◽  
Framework Approach ◽  
Group Meetings

ObjectivesTo evaluate the feasibility of a new approach to paediatric research whereby we involved children in analysing qualitative data, and to reflect on the involvement process.SettingThis was a single-centre, qualitative study in the Netherlands. It consisted of research meetings with individual children at home (Phase I) or group meetings at school (Phase II). In Phase I, we identified themes from a video interview during five one-on-one meetings between a child co-researcher and the adult researcher. In Phase II, during two group meetings, we explored the themes in detail using fragments from 16 interviews.ParticipantsWe involved 14 school children (aged 10 to 14 years) as co-researchers to analyse children’s interviews about their experience while participating in medical research. Notes were taken, and children provided feedback. A thematic analysis was performed using a framework approach.ResultsAll co-researchers identified themes. The time needed to complete the task varied, as did the extent to which the meetings needed to be structured to improve concentration. The children rated time investment as adequate and they considered acting as co-researcher interesting and fun, adding that they had learnt new skills and gained new knowledge. The experience also led them to reflect on health matters in their own lives. The adult researchers considered the process relatively time intensive, but the project did result in a more critical assessment of their own work.ConclusionThe new, two-phase approach of involving children to help analyse qualitative data is a feasible research method. The novelty lies in involving children to help identify themes from original interview data, thereby limiting preselection of data by adults, before exploring these themes in detail. Videos make it easier for children to understand the data and to empathise with the interviewees, and limits time investment.

S-1-based concomitant chemoradiotherapy for locally advanced non-small cell lung cancer: Two phase I trials from Okayama Lung Cancer Study Group (OLCSG)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 7547-7547
Author(s):  
Y. Fujiwara ◽  
K. Kiura ◽  
N. Takigawa ◽  
K. Hotta ◽  
D. Kishino ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Febrile Neutropenia ◽  
Phase I ◽  
Locally Advanced ◽  
Small Cell ◽  
Phase I Trials ◽  
Small Cell Lung ◽  
Two Phase ◽  
Grade 3 ◽  
Experienced Grade

7547 Background: Chemoradiotherapy (CRT) is a standard treatment for unresectable locally advanced non-small cell lung cancer (LA-NSCLC), but the treatment outcomes have remained unsatisfied. Thus, more effective and feasible CRT is urgently needed to improve their survival. S-1 is a newly developed oral 5-fluorouracil derivative and has synergistic effects with radiation. However, the role of S-1 in CRT for LA-NSCLC has been undetermined. Methods: We conducted two phase I trials to define the maximum tolerated doses (MTDs) and dose-limiting toxicities (DLTs) of S-1-based chemotherapy when combined with concurrent thoracic radiation (total dose of 60 Gy with 2 Gy per daily fraction) for LA-NSCLC. OLCSG 0501 was designed to evaluate the two cycles of combination of S-1 (days 1–14) and cisplatin (days 1 and 8) for patients aged 75 or younger. S-1/cisplatin dosages (mg/m2) were escalated as follows: 60/30, 60/40, 70/40, 80/40, and 80/50. The other trial, OLCSG 0502, recruited patients aged 76 or older and evaluated S-1 alone. S-1 dosages (mg/m2) were increased as follows: 60, 70, and 80. Results: A total of 44 previously untreated LA-NSCLC patients were enrolled (22 in both trials). The MTDs for S-1/cisplatin and S-1 alone were determined to be 80 mg/m2/day / 50 mg/m2 and 80 mg/m2/day, respectively. In the OLCSG 0501, DLTs included febrile neutropenia, thrombocytopenia, bacterial pneumonia and delayed second cycle of chemotherapy. No patient experienced grade 3 or more acute radiation pneumonitis and only one patient experienced grade 3 radiation esophagitis. In the OLCSG 0502, the DLTs were febrile neutropenia, stomatitis and delayed second cycle of chemotherapy. The overall response rates in OLCSG 0501 and OLCSG 0502 were 86.4% and 59.1%, respectively. Conclusions: These results indicate that S-1-based concomitant CRT would be a feasible treatment option and further phase II trials are currently under way. No significant financial relationships to disclose.

Novel organic arsenic molecule darinaparsin: Development of IV and oral forms

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 8501-8501 ◽  
Author(s):  
I. Lossos ◽  
M. D. Craig ◽  
M. S. Tallman ◽  
R. V. Boccia ◽  
P. R. Conkling ◽  
...  
Keyword(s):  
Phase I ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Complete Response ◽  
Median Number ◽  
Two Phase ◽  
Phase I Studies ◽  
Advanced Malignancies

8501 Background: Darinaparsin (ZIO-101) is a novel organic arsenical active against diverse cancers in vitro, and in vivo. Darinaparsin i.v. activity in lymphoma is being evaluated in a phase II study. Darinaparsin is orally bioavailable; the oral form is being investigated in two phase I studies in patients with advanced malignancies. Methods: Phase II trial is being conducted in patients diagnosed with advanced lymphomas who had ≥ 1 prior therapy. Patients receive 300 mg/m2/day of darinaparsin i.v. for 5 consecutive days every 28 days. Efficacy and safety are evaluated by standard criteria. Phase I oral dose escalation studies are being conducted in patients with advanced malignancies and explore safety, MTD, DLTs and preliminary efficacy of continuous and intermittent dosing schedules. Starting continuous dose is 100 mg BID for 3 weeks with 1 week rest, starting intermittent dose is 300 mg twice weekly for 3 weeks followed by 1 week rest. Results: The phase II study has accrued 28 lymphoma patients (21 non-Hodgkin's, 7 Hodgkin's); median age at baseline 61 years, ECOG ≤2, median number of prior therapies 3. Seventeen subjects have received at least 2 cycles of darinaparsin and are evaluable for efficacy. Of these, 1 subject (PTCL) has achieved a complete response, 3 - partial responses (2 marginal zone, 1 Hodgkin's), and 4 stable disease (2 PTCL, 1 DLBCL, 1 Hodgkin's). A total of 63 cycles of darinaparsin have been administered to subjects with lymphoma. No Gr. 3 or higher drug-related AEs were reported. Two SAEs were considered possibly drug-related (fall; neutropenic fever). Phase I studies accrued 35 patients; median age at baseline 58 years, ECOG ≤2, median number of prior therapies 3. Predominant tumor types include: colorectal (17), pancreatic (3), NHL (3). Current darinaparsin dose levels: continuous 200 mg BID, 2× weekly 900 mg. Of 18 patients evaluable for efficacy, 10 demonstrate SD ≥ 3 cycles. Oral darinaparsin bioavailability is 58%. Drug-related AEs include nausea/vomiting, fatigue, decreased appetite/anorexia. Conclusions: Darinaparsin is active in heavily pretreated patients with advanced lymphoma and has been very well tolerated. Oral darinaparsin is also well tolerated, and shows early activity. [Table: see text]

Phase I trial of nab-paclitaxel administered concurrently with radiotherapy in patients with locally advanced inoperable pancreatic adenocarcinoma (ART in LAP).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16796-e16796
Author(s):  
Amitesh Chandra Roy ◽  
Muhammad Nazim Abbas ◽  
Timothy Jay Price ◽  
Nimit Singhal ◽  
Sina Vatandoust ◽  
...  
Keyword(s):  
Febrile Neutropenia ◽  
Phase I ◽  
Pancreatic Adenocarcinoma ◽  
Phase Ii ◽  
Phase Ii Study ◽  
External Beam Radiotherapy ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Weekly Schedule ◽  
Study Dose

e16796 Background: Locally advanced pancreatic adenocarcinoma (LAPC) carries a poor prognosis with median overall survival of 12-18m. The optimal treatment is controversial. Nab-paclitaxel is active in advanced pancreatic cancer and has exhibited radio-sensitising anti-tumour efficacy. Methods: We conducted an investigator-initiated open-label, phase-I dose escalation trial of nab-paclitaxel with standard external beam radiotherapy (EBRT). All patients had biopsy-proven, untreated, localised, inoperable pancreatic adenocarcinoma; Patients received nab-paclitaxel on a weekly schedule for 6 weeks, concurrently with EBRT. A 3+3 cohort design was employed, with doses of nab-paclitaxel increasing from 25 mg/m2 (cohort 1), to 50 mg/m2 (cohort 2), 75 mg/m2 (cohort 3) and 100 mg/m2 (cohort 4). This principal objective of the trial was to establish the maximum tolerated dose (MTD) of nab-paclitaxel given concurrently with radiotherapy. Secondary objectives included safety and efficacy evaluation, including response rate, median PFS, median and 1- year OS. Results: Fourteen patients were recruited to the study, with a median age of 69 (range 40-86). 69% had a head or neck of pancreas tumour. Majority of patients had grade 1 or 2 toxicities with nausea (92%), fatigue (69%), diarrhoea (54%) and vomiting (54%) being the most common. Three patients were recruited in each of the first three cohorts, without any dose limiting toxicities (DLT). In cohort 4, DLT of febrile neutropenia and enterocolitis was observed in patient 1. The cohort was expanded with a subsequent DLT of febrile neutropenia and enterocolitis observed in patient 5. Both DLT events lead to death (grade 5). The MTD and recommended phase II study dose has been established as 75mg/ m2. The disease control (PR and SD) rate was 67%, median PFS 4.7 months (95% CI 2.5-27.5), 1 year OS 43% and median OS 11.4 months (95%CI 6.37-25.2). Conclusions: The combination of weekly nab-paclitaxel and fractionated radiation was generally well-tolerated at doses of nab-paclitaxel below 100 mg/m2. There were two treatment related DLTs leading to death in the nab-paclitaxel 100 mg/m2 cohort. The MTD and recommended phase II study dose for nab-paclitaxel combined with radiation therapy in the treatment of LAPC is 75mg/m2. Clinical trial information: ACTRN12613001013752 .

Acquisition and Extinction of a Runway Response under Odor-Intensified or -Minimized Conditions, Within-Subjects Trial Administration, and a One-Minute Intertrial Interval

1974 ◽  
Vol 38 (1) ◽  
pp. 119-129 ◽  
Author(s):  
Robert E. Prytula ◽  
James H. Payne
Keyword(s):  
Phase Ii ◽  
Intertrial Interval ◽  
Albino Rats ◽  
Two Phase ◽  
Phase Study ◽  
Within Subjects

A two-phase study was conducted during which 2 groups of albino rats received the same schedule of reward and nonreward, the same magnitude of reward and nonreward confinement, the same intertrial and intersubject intervals and the same trial order. The only difference was that one group of Ss was trained and extinguished under an odor-intensified condition, whereas the second group was trained and extinguished under an odor-reduced condition. In the goal segment Ss trained under an odor-intensified condition discriminated the schedule perfectly during acquisition and were less resistant to extinction than Ss trained under the odor-reduced condition. Following a 2-wk. interval, Phase II, the groups underwent acquisition and extinction again under reversed odor-conditions. The results were replicated within the study.

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