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.

scholarly journals COVID-19 and Radiation Oncology: a 2-phase planning in a mono-institutional experience in Central Italy

2020 ◽  
Author(s):  
Luciana Caravatta ◽  
Consuelo Rosa ◽  
Maria Bernadette Di Sciascio ◽  
Andrea Tavella Scaringi ◽  
Angelo Di Pilla ◽  
...  
Keyword(s):  
Phase I ◽  
Healthcare Professionals ◽  
Central Italy ◽  
Treatment Interruption ◽  
Radiotherapy Planning ◽  
Linear Accelerators ◽  
Cancer Treatments ◽  
Tumor Boards ◽  
Institutional Experience ◽  
Two Phases

Abstract Background: COVID-19 in Italy has led to a reorganization of hospital activities with risks of cancer treatments discontinuity. We report a management model in the two phases of the COVID-19 emergency, lockdown phase I and post-lockdown phase II.Methods: Actions were planned in the two phases: workloads of the visits and radiotherapy planning, dedicated routes, measures for triage areas, management of suspected and positive COVID-19 cases, personal protective equipment, environments andintra-institutional meetings and tumor boards management.Results: Comparing our radiotherapy activity in the period March 9- May 4, 2019 with the same period of 2020 in full phase I of the COVID-19 emergency, no changes were observed.First radiotherapy visits, Simulation Computed Tomography and Linear Accelerators treatments were 123, 137 and 151 in 2019 respect to 121, 135 and 170 in 2020.There were no cases of COVID-19 positivity recorded either in patients or in healthcare professionals who were all negative to the buffers performed.Conclusions: The model planned in our experience in both phases has guaranteed continuity of radiotherapy treatments without workload reduction nor treatment interruption ensuring safety of cancer patients, environments and staff.

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 A pareto ensemble based spectral clustering framework

2020 ◽  
Author(s):  
Juanjuan Luo ◽  
Huadong Ma ◽  
Dongqing Zhou
Keyword(s):  
Phase I ◽  
Phase Ii ◽  
Spectral Clustering ◽  
Clustering Algorithms ◽  
Divide And Conquer ◽  
Nonzero Entry ◽  
Similarity Matrix ◽  
Diversity Preservation ◽  
Two Phases ◽  
Matrix Construction

Abstract Similarity matrix has a significant effect on the performance of the spectral clustering, and how to determine the neighborhood in the similarity matrix effectively is one of its main difficulties. In this paper, a “divide and conquer” strategy is proposed to model the similarity matrix construction task by adopting Multiobjective evolutionary algorithm (MOEA). The whole procedure is divided into two phases, phase I aims to determine the nonzero entries of the similarity matrix, and Phase II aims to determine the value of the nonzero entries of the similarity matrix. In phase I, the main contribution is that we model the task as a biobjective dynamic optimization problem, which optimizes the diversity and the similarity at the same time. It makes each individual determine one nonzero entry for each sample, and the encoding length decreases to O(N) in contrast with the non-ensemble multiobjective spectral clustering. In addition, a specific initialization operator and diversity preservation strategy are proposed during this phase. In phase II, three ensemble strategies are designed to determine the value of the nonzero value of the similarity matrix. Furthermore, this Pareto ensemble framework is extended to semi-supervised clustering by transforming the semi-supervised information to constraints. In contrast with the previous multiobjective evolutionary-based spectral clustering algorithms, the proposed Pareto ensemble-based framework makes a balance between time cost and the clustering accuracy, which is demonstrated in the experiments section.

scholarly journals Involvement of NO in Antinociception of NSAIDS in Murine Formalin Hind Paw Assay

Drug Research ◽  
2020 ◽  
Vol 70 (04) ◽  
pp. 145-150 ◽  
Author(s):  
Viviana Noriega ◽  
Hugo F. Miranda ◽  
Juan Carlos Prieto ◽  
Ramón Sotomayor-Zárate ◽  
Fernando Sierralta
Keyword(s):  
Phase I ◽  
Phase Ii ◽  
Dose Response ◽  
Rank Order ◽  
Linear Regression Analysis ◽  
Second Phase ◽  
Response Curves ◽  
Before And After ◽  
Two Phases ◽  
Phase Phase

AbstractThere are different animal models to evaluate pain among them the formalin hind paw assay which is widely used since some of its events appear to be similar to the clinical pain of humans. The assay in which a dilute solution of formalin is injected into the dorsal hindpaw of a murine produces two ‘phases’ of pain behavior separated by a inactive period. The early phase (Phase I) is probably due to direct activation of nociceptors and the second phase (Phase II) is due to ongoing inflammatory input and central sensitization. Mice were used to determine the potency antinociceptive of piroxicam (1,3,10,and 30 mg/kg), parecoxib (0.3, 1,3,10 and 30 mg/kg), dexketoprofen (3,10,30 and 100 mg/kg) and ketoprofen (3,10,30 and 100 mg/kg). Dose-response for each NSAIDs were created before and after 5 mg/kg of L-NAME i.p. or 5 mg/kg i.p. of 7-nitroindazole. A least-squares linear regression analysis of the log dose–response curves allowed the calculation of the dose that produced 50% of antinociception (ED50) for each drug. The ED50 demonstrated the following rank order of potency, in the phase I: piroxicam > dexketoprofen > ketoprofen > parecoxib and in the phase II: piroxicam > ketoprofen > parecoxib > dexketoprofen. Pretreatment of the mice with L-NAME or 7-nitroindazol induced a significant increase of the analgesic power of the NSAIDs, with a significant reduction of the ED50. It is suggested that NO may be involved in both phases of the trial, which means that nitric oxide regulates the bioactivity of NSAIDs.

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.

Identifying Criteria for Continuous Evaluation of Software Engineers for Reward and Recognition

2016 ◽  
Vol 7 (4) ◽  
pp. 61-78 ◽  
Author(s):  
Sreejith S. S. ◽  
Muthu Mathirajan
Keyword(s):  
Phase I ◽  
Phase Ii ◽  
Employee Performance ◽  
Exploratory Research ◽  
Structured Interviews ◽  
Continuous Evaluation ◽  
Software Engineers ◽  
Two Phases ◽  
R Process ◽  
Reward And Recognition

Reward and Recognition (R&R) should be given to employees in a timely manner, based on continuous evaluation of their performance. Success of an R&R process lies in clear and well defined criteria for continuous evaluation of employee performance. Often such criteria are decided by the organization with no input from the employees. The purpose of this paper is to use qualitative research methods to explore and identify the criteria to be used for continuous employee performance evaluation for R&R in Information Technology organizations, from the perspectives of software engineers (SEs) and project managers (PMs). Exploratory research was conducted in two phases. In Phase I, unstructured interviews are used to elicit information from 7 SEs. Caselets are prepared based on these interviews and 19 criteria are identified. In Phase II, the criteria identified in Phase I are confirmed using content analysis of semi-structured interviews, conducted on relatively larger group of SEs (in stage 1) and PMs (in stage 2). Additionally, 12 criteria are also identified in Phase II. Collectively 31 criteria are identified. The proposed criteria set is expected to comprehensively cover the SE performance on a continuous basis in various dimensions to award R&R.

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.

Assessing Hospital Disaster Readiness Over Time at the US Department of Veterans Affairs

2016 ◽  
Vol 32 (1) ◽  
pp. 46-57 ◽  
Author(s):  
Claudia Der-Martirosian ◽  
Tiffany A. Radcliff ◽  
Alicia R. Gable ◽  
Deborah Riopelle ◽  
Farhad A. Hagigi ◽  
...  
Keyword(s):  
Phase I ◽  
Emergency Management ◽  
Phase Ii ◽  
Veterans Affairs ◽  
Assessment Tools ◽  
Department Of Veterans Affairs ◽  
The Us ◽  
Two Phases ◽  
Hospital Readiness ◽  
Over Time

AbstractIntroductionThere have been numerous initiatives by government and private organizations to help hospitals become better prepared for major disasters and public health emergencies. This study reports on efforts by the US Department of Veterans Affairs (VA), Veterans Health Administration, Office of Emergency Management’s (OEM) Comprehensive Emergency Management Program (CEMP) to assess the readiness of VA Medical Centers (VAMCs) across the nation.Hypothesis/ProblemThis study conducts descriptive analyses of preparedness assessments of VAMCs and examines change in hospital readiness over time.MethodsTo assess change, quantitative analyses of data from two phases of preparedness assessments (Phase I: 2008-2010; Phase II: 2011-2013) at 137 VAMCs were conducted using 61 unique capabilities assessed during the two phases. The initial five-point Likert-like scale used to rate each capability was collapsed into a dichotomous variable: “not-developed=0” versus “developed=1.” To describe changes in preparedness over time, four new categories were created from the Phase I and Phase II dichotomous variables: (1) rated developed in both phases; (2) rated not-developed in Phase I but rated developed in Phase II; (3) rated not-developed in both phases; and (4) rated developed in Phase I but rated not- developed in Phase II.ResultsFrom a total of 61 unique emergency preparedness capabilities, 33 items achieved the desired outcome – they were rated either “developed in both phases” or “became developed” in Phase II for at least 80% of VAMCs. For 14 items, 70%-80% of VAMCs achieved the desired outcome. The remaining 14 items were identified as “low-performing” capabilities, defined as less than 70% of VAMCs achieved the desired outcome.Conclusion:Measuring emergency management capabilities is a necessary first step to improving those capabilities. Furthermore, assessing hospital readiness over time and creating robust hospital readiness assessment tools can help hospitals make informed decisions regarding allocation of resources to ensure patient safety, provide timely access to high-quality patient care, and identify best practices in emergency management during and after disasters. Moreover, with some minor modifications, this comprehensive, all-hazards-based, hospital preparedness assessment tool could be adapted for use beyond the VA.Der-MartirosianC, RadcliffTA, GableAR, RiopelleD, HagigiFA, BrewsterP, DobalianA. Assessing hospital disaster readiness over time at the US Department of Veterans Affairs. Prehsop Disaster Med. 2017;32(1):46–57.

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