Multi-institutional quality care initiative (QCI) to improve the care of patients with invasive bladder cancer (BlCa).

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 298-298 ◽  
Author(s):  
Bernard H. Bochner ◽  
Andrew Feifer ◽  
Dahlia Sperling ◽  
Joseph W Mashni ◽  
Dean F. Bajorin ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Phase 1 ◽  
Quality Care ◽  
Data Entry ◽  
Background Level ◽  
Fold Increase ◽  
Phase 2 ◽  
Two Phase ◽  
Survey System

298 Background: Level 1 evidence supports a survival benefit for BlCa pts that receive periop cisplatin chemotherapy in addition to radical cystectomy (RC). Underutilization of multimodal therapy has been reported nationally. We instituted a multicenter QCI to improve the use of periop chemotherapy. Methods: A two phase effort was initiated at 16 academic institutions. Phase 1 was initiated in 2010 and designed to evaluate baseline patterns of periop chemotherapy use for T2-4N0M0 BlCa pts that underwent RC between 2003-2008. Phase 2 was a prospective QCI. The quality indicators included (1) referral to medical oncology for consideration of multimodality therapy, (2) neoadjuvant, if recommended, be cisplatin based and at least 3 cycles, (3) adjuvant, if recommended, be cisplatin based and at least 3 cycles, (4) all treatment be completed within 6 months. Data on all eligible pts were collected prospectively for 12 months on a web-based survey system. Results: All 16 centers participated in phase 1. Of 4,344 pts on whom data was available, 34% received periop chemotherapy. Neoadjuvant and adjuvant therapy use was 14% and 20%, respectively. 65% of pts receiving periop chemotherapy were treated with a cisplatin-based regimen. Of those treated neoadjuvantly, cisplatin was received in 70% of cases. Nine of the 16 institutions completed phase 2 data collection. Over 700 pts that underwent RC were evaluated. 395 pts with T2-4N0M0 disease were deemed eligible for data entry. Fifty-six percent of eligible pts received periop systemic chemotherapy. Of this 56%, 47% received neoadjuvant cisplatin chemotherapy and 9% received adjuvant cisplatin chemotherapy. This represented a 64.7% increase in the use of any periop chemotherapy and a 3.4 fold increase in neoadjuvant chemotherapy compared to baseline data. Conclusions: We have successfully completed a multi-institutional QCI to improve the use of periop chemotherapy in pts undergoing RC for resectable, non-metastatic bladder cancer. Our data demonstrates that significant improvements can be achieved in not only overall use of periop chemotherapy but most notably in the use of neoadjuvant chemotherapy.

Endometrial Adenocarcinoma in SurePath™ Cervical Samples: Cytological Features Revisited

2016 ◽  
Vol 60 (1) ◽  
pp. 46-52 ◽  
Author(s):  
Nalini Gupta ◽  
John Crossley ◽  
Nick Dudding ◽  
John H.F. Smith
Keyword(s):  
Phase 1 ◽  
Endometrial Adenocarcinoma ◽  
Nuclear Chromatin ◽  
Phase 2 ◽  
Cervical Lesions ◽  
Two Phase ◽  
Endometrial Cells ◽  
Phase Study ◽  
Cytological Features ◽  
Liquid Based Cytology

Objective: The cytomorphological criteria of malignant endometrial lesions in cervical samples are less well described than those of cervical lesions. We wished to investigate if there were features in SurePath™ liquid-based cytology samples that would facilitate more accurate differentiation between benign and malignant endometrial cells. Study Design: This was a two-phase study, with a review of all SurePath™ samples reported as endometrial adenocarcinoma (n = 42) evaluating 12 cytological features in the first phase. In phase 2 (test set), all initial cases plus an additional 83 cases were reviewed using these 12 cytological features to predict the outcome. Results: Out of 12 cytological features evaluated in phase 1 (training set), nuclear chromatin pattern, apoptotic bodies and tingible body macrophages were found to be the most significant features determining malignant histological outcome. These 12 cytological features were re-evaluated in phase 2 (n = 125). Of 125 cases, 54 had a benign and 71 had a malignant or premalignant histological outcome, with a positive predictive value of 56.8%. Conclusion: Granular nuclear chromatin, tingible body macrophages and apoptosis in the background are the most significant factors in determining whether endometrial cells present in cervical samples represent malignancy or are benign. Using these features, relatively accurate predictions of endometrial pathology can be made.

scholarly journals Developing a realist theory of psychosocial rehabilitation: the Clubhouse model

2021 ◽  
Author(s):  
Christina Mutschler ◽  
Jen Rouse ◽  
Kelly McShane ◽  
Criss Habal-Brosek
Keyword(s):  
Phase 1 ◽  
Psychosocial Rehabilitation ◽  
Theory Development ◽  
Realist Evaluation ◽  
Self Determination ◽  
Phase 2 ◽  
Two Phase ◽  
Realist Theory ◽  
Clubhouse Model ◽  
Two Phases

Background Psychosocial rehabilitation is a service that supports recovery from mental illness by providing opportunities for skill development, self-determination, and social interaction. One type of psychosocial rehabilitation is the Clubhouse model. The purpose of the current project was to create, test, and refine a realist theory of psychosocial rehabilitation at Progress Place, an accredited Clubhouse. Method Realist evaluation is a theory driven evaluation that uncovers contexts, mechanisms, and outcomes, in order to develop a theory as to how a program works. The current study involved two phases, encompassing four steps: Phase 1 included (1) initial theory development and (2) initial theory refinement; and Phase 2 included (3) theory testing and (4) refinement. Results The data from this two-phase approach identified three demi-regularities of recovery comprised of specific mechanisms and outcomes: the Restorative demi-regularity, the Reaffirming demi-regularity, and the Re-engaging demi-regularity. The theory derived from these demi-regularities suggests that there are various mechanisms that produce outcomes of recovery from the psychosocial rehabilitation perspective, and as such, it is necessary that programs promote a multifaceted, holistic perspective on recovery. Conclusions The realist evaluation identified that Progress Place promotes recovery for members. Additional research on the Clubhouse model should be conducted to further validate that the model initiates change and promotes recovery outcomes.

scholarly journals A Novel Approach to Practice-Based Learning and Improvement Using a Web-Based Audit and Feedback Module

2014 ◽  
Vol 6 (3) ◽  
pp. 541-546 ◽  
Author(s):  
Joel C. Boggan ◽  
George Cheely ◽  
Bimal R. Shah ◽  
Randy Heffelfinger ◽  
Deanna Springall ◽  
...  
Keyword(s):  
Phase 1 ◽  
Data Entry ◽  
Audit And Feedback ◽  
Phase 2 ◽  
Online Data ◽  
Web Based ◽  
Online Tool ◽  
Novel Approach ◽  
Patients With Diabetes ◽  
Personal Performance

Abstract Background Systematically engaging residents in large programs in quality improvement (QI) is challenging. Objective To coordinate a shared QI project in a large residency program using an online tool. Methods A web-based QI tool guided residents through a 2-phase evaluation of performance of foot examinations in patients with diabetes. In phase 1, residents completed reviews of health records with online data entry. Residents were then presented with personal performance data relative to peers and were prompted to develop improvement plans. In phase 2, residents again reviewed personal performance. Rates of performance were compared at the program and clinic levels for each phase, with data presented for residents. Acceptability was measured by the number of residents completing each phase. Feasibility was measured by estimated faculty, programmer, and administrator time and costs. Results Seventy-nine of 86 eligible residents (92%) completed improvement plans and reviewed 1471 patients in phase 1, whereas 68 residents (79%) reviewed 1054 patient charts in phase 2. Rates of performance of examination increased significantly between phases (from 52% to 73% for complete examination, P < .001). Development of the tool required 130 hours of programmer time. Project analysis and management required 6 hours of administrator and faculty time monthly. Conclusions An online tool developed and implemented for program-wide QI initiatives successfully engaged residents to participate in QI activities. Residents using this tool demonstrated improvement in a selected quality target. This tool could be adapted by other graduate medical education programs or for faculty development.

scholarly journals Whole system approaches to health in higher education

2019 ◽  
Vol 119 (4) ◽  
pp. 246-258
Author(s):  
Mark Dooris ◽  
Alan Farrier ◽  
Susan Powell ◽  
Maxine Holt
Keyword(s):  
Higher Education ◽  
Phase 1 ◽  
International Perspective ◽  
Phase 2 ◽  
Structured Interviews ◽  
Two Phase ◽  
Content Type ◽  
Key Issues ◽  
Strategic Influence ◽  
The Uk

Purpose The purpose of this paper is to report on an evaluation of the UK Healthy Universities Network (UKHUN), which explored engagement of network members; identified what members value about the network; examined facilitators and barriers to engagement; and informed the network’s future development. Design/methodology/approach The study was a two phase mixed-method study, with participants being staff from Higher Education institutions. Phase 1 involved a documentary review and an online 14-question survey (n=32). Phase 2 comprised follow-up semi-structured interviews and focus groups, conducted using Skype (n=11). These were audio recorded and transcripts were thematically analysed in a two-stage process. Findings A number of key themes emerged from the thematic analysis: value of network meetings and events; popularity of the network website; increased communication and collaboration; sense of leadership offered by the network; interest and inclusion of an international perspective; importance of institutional support. Research limitations/implications Only six universities who are involved in the network took part in Phase 2. Although a range of organisations were chosen purposively, it is possible that additional key issues at other universities were excluded. Originality/value The UKHUN is valued by its membership, particularly its biannual meetings, online presence, leadership, ethos and communication methods. Key barriers include the capacity of staff to attend meetings and contribute to the network, influenced by a lack of institutional commitment and prioritisation. Findings from the evaluation have informed a “refresh” of the network’s website and a revision of its membership structure, as well as guiding its positioning to achieve greater strategic influence.

A computationally fast approach to maximum‐likelihood deconvolution

Geophysics ◽  
1984 ◽  
Vol 49 (5) ◽  
pp. 550-565 ◽  
Author(s):  
Chong‐Yung Chi ◽  
Jerry M. Mendel ◽  
Dan Hampson
Keyword(s):  
Maximum Likelihood ◽  
Initial Conditions ◽  
Phase 1 ◽  
Real Data ◽  
Phase 2 ◽  
Statistical Parameters ◽  
Two Phase ◽  
Nonminimum Phase ◽  
Fast Approach ◽  
Fine Adjustment

In this paper we derive and implement a maximum‐likelihood deconvolution (MLD) algorithm, based on the same channel and statistical models used by Kormylo and Mendel (1983a), that leads to many fewer computations than their MLD algorithm. Both algorithms can simultaneously estimate a nonminimum phase wavelet and statistical parameters, detect locations of significant reflectors, and deconvolve the data. Our MLD algorithm is implemented by a two‐phase block component method (BCM). The phase‐1 block functions like a coarse adjustment of unknown quantities and provides a set of good initial conditions for the phase‐2 block, which functions like a fine adjustment of unknown quantities. We demonstrate good performance of our algorithm for both synthetic and real data.

Ex Vivo Pharmacologic Modulation in a Nutrient-Rich Medium to Accelerate Engraftment of Human Umbilical Cord Blood

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 3807-3807
Author(s):  
Corey S Cutler ◽  
Daniel Shoemaker ◽  
Peter Westervelt ◽  
Daniel R. Couriel ◽  
Sumithra Vasu ◽  
...  
Keyword(s):  
Gene Expression ◽  
Umbilical Cord Blood ◽  
Ex Vivo ◽  
Phase 1 ◽  
Fold Increase ◽  
Phase 2 ◽  
Employment Equity ◽  
Phase 2 Trial ◽  
Equity Ownership ◽  
Neutrophil Engraftment

Abstract Umbilical cord blood (UCB) offers many potential advantages as a source of hematopoietic stem cells (HSCs) for allogeneic transplantation, including ease of collection, rapid availability, flexibility of HLA-matching, lower rates of GvHD and potentially lower relapse rates. However, the low HSC content of UCB compared to other graft sources results in a prolonged time to engraftment, and higher rates of graft failure and early mortality. Pulse ex vivo exposure of HSCs to 16,16-dimethyl PGE2 (FT1050) has been demonstrated to enhance HSC engraftment potential, which could benefit clinical UCB transplant. FT1050 modulation promotes multiple mechanisms, including increased proliferation, reduced apoptosis, and improved migration and homing [North 2007&2009; Hoggatt 2009]. Improved HSC homing is mediated by induction of CXCR4 gene expression leading to increased cell surface CXCR4. Further optimization of the UCB modulation process demonstrated that incubation with 10µM FT1050 for 2 hrs at 37C resulted in a maximal biological response of the FT1050-UCB (ProHema®). A Phase 1 trial was performed to evaluate the safety of FT1050-UCB paired with an unmanipulated UCB unit in reduced-intensity double UCBT (dUCBT) [Cutler 2013]. We observed durable, multi-lineage engraftment of FT1050-UCB with acceptable safety. Earlier neutrophil engraftment was observed relative to historical controls (median 17.5 vs. 21 days (historical control), p=0.045), coupled with preferential engraftment of the FT1050-UCB unit in 10 of 12 subjects. A Phase 2 multi-center clinical trial of FT1050-UCB in adult patients undergoing dUCBT for hematologic malignancies was then initiated. Subjects are randomized 2:1 to FT1050-UCB-containing vs. standard dUCBT after high-dose conditioning. The primary endpoint is a categorical analysis of neutrophil engraftment using a pre-specified control median. Data on the initial 11 subjects, of which 8 were randomized to receive FT1050-UCB, continue to demonstrate acceptable safety with adverse events attributed to FT1050-UCB limited primarily to common infusion-related side effects. Of the 8 FT1050-UCB subjects, 1 died prior to neutrophil engraftment, with the remaining 7 subjects engrafting at a median of 28 days vs. 31 days for the 3 control subjects. With median overall follow-up of 16.1 months, 4 of 8 subjects on the FT1050-UCB arm are alive with a median survival not reached (> 11.0 months). 1 of 3 control subjects is alive with median survival of 6.0 months. During the clinical translation process, the media used during FT1050 modulation of UCB was identified as a key variable. Standard UCB washing media, consisting of a nutrient-free saline solution of low molecular weight dextran and human serum albumin (LMD/HSA), is used clinically to stabilize fragile cells post-thaw by reducing lysis. This media was used in the Phase 1 trial and to initiate Phase 2. Early during the Phase 2 trial, we identified a novel cell-stabilizing nutrient-rich formulation (NRM), containing glucose, amino acids and other HSC-supporting nutrients that promoted full FT1050 modulation of UCB and increased cell viability. The expression of key FT1050-pathway genes was significantly higher with NRM compared to intermediate levels observed with LMD/HSA. Modulation of human CD34+ (hCD34+) cells with FT1050 in NRM led to an 8-fold increase over LMD/HSA in induced CXCR4 gene expression (20-fold total), which translated to significantly increased surface CXCR4 protein. In vivo homing models demonstrated that UCB CD34+ cells modulated with FT1050 in NRM resulted in a 2.2-fold homing increase relative to vehicle (p < 0.001) compared to a 1.6-fold increase with LMD/HSA (p = 0.002), with a significant difference between the two media conditions (p = 0.04). A xenotransplantation study in NSG mice with hCD34+ cells modulated with FT1050 in either NRM or LMD/HSA demonstrated a 2-fold increase in circulating hCD45+ cells 12-weeks post-transplant with NRM (p = 0.007; unpaired t-test). These findings supported the incorporation of NRM into the FT1050-UCB manufacturing process in order to further improve its clinical engraftment potential. Enrollment of a 60-patient Phase 2 trial has been initiated that incorporates this manufacturing change. Disclosures Shoemaker: Fate Therapeutics: Employment, Equity Ownership. Rezner:Fate Therapeutics: Employment. Guerrettaz:Fate Therapeutics: Employment. Robbins:Fate Therapeutics: Employment. Medcalf:Fate Therapeutics: Employment. Wolchko:Fate Therapeutics: Employment, Equity Ownership. Ferraro:Fate Therapeutics: Employment. Multani:Fate Therapeutics: Employment.

scholarly journals Early Diagnostic Marker Panel Determination for Microarray Based Clinical Studies

2005 ◽  
Vol 4 (1) ◽  
Author(s):  
Jochen Jaeger ◽  
Dieter Weichenhan ◽  
Boris Ivandic ◽  
Rainer Spang
Keyword(s):  
Phase 1 ◽  
Classification Model ◽  
Marker Genes ◽  
Phase 2 ◽  
Two Phase ◽  
Marker Panel ◽  
Performance Loss ◽  
Genome Wide ◽  
Number Of Patients ◽  
Cost Efficient

We present a novel, cost efficient two-phase design for predictive clinical gene expression studies: early marker panel determination (EMPD). In Phase-1, genome-wide microarrays are used only for a small number of individual patient samples. From this Phase-1 data a panel of marker genes is derived. In Phase-2, the expression values of these marker panel genes are measured for a large group of patients and a predictive classification model is learned from this data. Phase-2 does not require the use of expensive whole genome microarrays, thus making EMPD a cost efficient alternative for current trials. The expected performance loss of EMPD is compared to designs which use genome-wide microarrays for all patients. We also examine the trade-off between the number of patients included in Phase-1 and the number of marker genes required in Phase-2. By analysis of five published datasets we find that in Phase-1 already 16 patients per group are sufficient to determine a suitable marker panel of 10 genes, and that this early decision compromises the final performance only marginally.

scholarly journals Stem cell factor amplifies newborn and sickle erythropoiesis in liquid cultures

Blood ◽  
1993 ◽  
Vol 81 (10) ◽  
pp. 2591-2599 ◽  
Author(s):  
RS Weinberg ◽  
JC Thomson ◽  
R Lao ◽  
G Chen ◽  
BP Alter
Keyword(s):  
Stem Cell ◽  
Progenitor Cells ◽  
Stem Cell Factor ◽  
Mononuclear Cells ◽  
Phase 1 ◽  
Newborn Infants ◽  
Cell Number ◽  
Phase 2 ◽  
Two Phase ◽  
Erythroid Progenitor

A two-phase liquid-culture system was used to substantially amplify and differentiate erythroblasts, starting with mononuclear cells from the blood of normal adults, newborn infants, and patients with sickle cell anemia. After the first 7 days (phase 1), in medium plus fetal bovine serum (FBS) alone, or in combination with stem cell factor (SCF) or conditioned medium (CM), the cell number was unchanged, and the cells all looked like lymphocytes. These cells were then diluted into medium with erythropoietin (Ep) alone, with Ep and either SCF or CM, or in methylcellulose with the same factors (phase 2). After 14 days in liquid phase 2 with SCF and Ep, the cell numbers increased an average of 30-fold in the sickle, 24-fold in the newborn, and 4-fold in the normal adult cultures; almost all the cells were erythroblasts and erythrocytes. SCF in phase 1 increased the number of late progenitors (CFU-E) assayed in methylcellulose, with the largest number in sickle, followed by newborn cultures and then adult cultures. We conclude that erythroid progenitor cells survive for at least 7 days without Ep (but with FBS). Progenitor cells are amplified, particularly with SCF. Later in culture, SCF with Ep increases the final number of differentiated erythroid cells. Both the early and the late effects of SCF are most effective in sickle, followed by newborn cultures and then adult cultures.

scholarly journals Enhancing Label Representations with Relational Inductive Bias Constraint for Fine-Grained Entity Typing

2021 ◽  
Author(s):  
Jinqing Li ◽  
Xiaojun Chen ◽  
Dakui Wang ◽  
Yuwei Li
Keyword(s):  
State Of The Art ◽  
Phase 1 ◽  
Phase 2 ◽  
Two Phase ◽  
Inductive Bias ◽  
Fine Grained ◽  
Wide Range ◽  
Dynamic Experiments ◽  
Novel Method ◽  
Public Datasets

Fine-Grained Entity Typing (FGET) is a task that aims at classifying an entity mention into a wide range of entity label types. Recent researches improve the task performance by imposing the label-relational inductive bias based on the hierarchy of labels or label co-occurrence graph. However, they usually overlook explicit interactions between instances and labels which may limit the capability of label representations. Therefore, we propose a novel method based on a two-phase graph network for the FGET task to enhance the label representations, via imposing the relational inductive biases of instance-to-label and label-to-label. In the phase 1, instance features will be introduced into label representations to make the label representations more representative. In the phase 2, interactions of labels will capture dependency relationships among them thus make label representations more smooth. During prediction, we introduce a pseudo-label generator for the construction of the two-phase graph. The input instances differ from batch to batch so that the label representations are dynamic. Experiments on three public datasets verify the effectiveness and stability of our proposed method and achieve state-of-the-art results on their testing sets.

Sample study protocol for adapting and/or translating the 5C scale to assess the psychological antecedents of vaccination

2019 ◽  
Author(s):  
Cornelia Betsch ◽  
Katrine Habersaat ◽  
Sergei Deshevoi ◽  
Dorothee K. Heinemeier ◽  
Natalia Kostenko ◽  
...  
Keyword(s):  
Study Protocol ◽  
Cultural Context ◽  
Phase 1 ◽  
Collective Responsibility ◽  
Phase 2 ◽  
Two Phase ◽  
Cultural Setting ◽  
Original Group ◽  
Vaccination Confidence ◽  
Item Scale

Background: Published in 2018, the 5C scale is psychometrically validated to assess five psychological antecedents of vaccination (confidence, complacency, constraints, calculation, and collective responsibility). The original version offers a validated English and German scale to assess these determinants with a short 5-item scale (1 item per antecedent) and a long 15-item scale (3-items per antecedent). As the original group of authors has received several requests about how to adapt the scale to another country, language, or cultural context, this sample study protocol provides guidance for this process. Here, we propose a two-phase process of how to adapt the 5C scale to a new country, language, or cultural setting. Methods: Phase 1 comprises the translation and the adaptation to a specific cultural context (if necessary). Phase 2 involves the validation of the translated and potentially expanded scale. Discussion: Following the suggested study protocol will allow better comparability across the data obtained from the scale when used in different countries, languages, and contexts—even if slight changes in the wording of the items are necessary. The data obtained from the 5C scale allows monitoring the antecedents of vaccination, and detecting potentially early warning signals. Consequently, data obtained from the 5C scale can support developing, implementing, and evaluating an intervention. The materials and the syntax for data analysis to support the process described in this protocol are available in https://osf.io/2agxe/.

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