Creating large scale telehealth network : A story from the USA by Adam Darkins, Vice President, Medical Affairs & Enterprise Technology Development, Medtronics, USA
Evidence Based Clinical Decision Support – An Enabler for Clinicians in 21st Century by Dr. Lalit Singh, Director for Content & Product Strategy, Elsevier, India
An Introduction to Clinical InformaticsCorinn Pope
Why should you care about clinical informatics? Because those who practice clinical informatics just may help our healthcare system get out of its funk and become an efficient, lean, and tech-savvy machine. Plus, the industry is growing and growing fast.
Creating large scale telehealth network : A story from the USA by Adam Darkins, Vice President, Medical Affairs & Enterprise Technology Development, Medtronics, USA
Evidence Based Clinical Decision Support – An Enabler for Clinicians in 21st Century by Dr. Lalit Singh, Director for Content & Product Strategy, Elsevier, India
An Introduction to Clinical InformaticsCorinn Pope
Why should you care about clinical informatics? Because those who practice clinical informatics just may help our healthcare system get out of its funk and become an efficient, lean, and tech-savvy machine. Plus, the industry is growing and growing fast.
Duality Technologies_Driving Secure Collaboration in Healthcare_mHealth IsraelLevi Shapiro
Presentation by Alon Kaufman, CEO, Duality Technologies, for the mHealth Israel community. Homomorphic encryption is used to protect patient privacy and data security.
Big Data and VistA Evolution, Theresa A. Cullen, MD, MSBrian Ahier
Presentation to Open Source Electronic Health Record Alliance (OSEHRA) Architecture Work Group by Theresa A. Cullen, MD, MS
Chief Medical Information Officer
Director, Health Informatics
Office of Informatics and Analytics
Veterans Health Administration
Department of Veterans Affairs
Virtual knowledge network NIMHANS Echo : Innovative tele- mentoring model for skilled capacity building in addiction & mental health by Prabhat Chand , NIMHANS, India
21st Century Act and its Impact on Healthcare ITCitiusTech
This document gives an overview, core objectives of the act and enumerates purpose of each part / division of the 21st Century Act. It lists down the sections of the act which have a direct impact on Healthcare IT and gives a brief overview of each section.This document also explains the impact of 21st Century Cures Act on regulatory bodies: FDA / NIH / HSS.
What you need to know about Meaningful Use 2 & interoperabilityCompliancy Group
Does this describe you?
·You are constantly challenged to stay abreast of the latest information on EHR integration and HIE interoperability, Meaningful Use stages, the Direct Project, clinician and patient portals, just to name a few.
·You walk a fine line between adopting health information technology for the good it can bring patient outcomes…….and for the good incentive dollars it can mean to your organization.
·You play a key role in ensuring your organization can attest for meaningful use.
Join Andy Nieto, Health IT Strategist at DataMotion where he’ll explain the key role that interoperability plays in Meaningful Use Stage 2 attestation including:
- What does interoperability really mean
- Why you can’t ignore interoperability
- How to achieve interoperability and make it meaningful
- What you need in order to attest
Dr Al Mulley: The Secret to Reducing Unwarranted VariationsThe King's Fund
Dr Al Mulley, Director of the Dartmouth Center for Health Care Delivery Science at Dartmouth College, introduces the theory behind good and bad health care variation, looking at the work of Dr Jack Wennberg in the United States.
Duality Technologies_Driving Secure Collaboration in Healthcare_mHealth IsraelLevi Shapiro
Presentation by Alon Kaufman, CEO, Duality Technologies, for the mHealth Israel community. Homomorphic encryption is used to protect patient privacy and data security.
Big Data and VistA Evolution, Theresa A. Cullen, MD, MSBrian Ahier
Presentation to Open Source Electronic Health Record Alliance (OSEHRA) Architecture Work Group by Theresa A. Cullen, MD, MS
Chief Medical Information Officer
Director, Health Informatics
Office of Informatics and Analytics
Veterans Health Administration
Department of Veterans Affairs
Virtual knowledge network NIMHANS Echo : Innovative tele- mentoring model for skilled capacity building in addiction & mental health by Prabhat Chand , NIMHANS, India
21st Century Act and its Impact on Healthcare ITCitiusTech
This document gives an overview, core objectives of the act and enumerates purpose of each part / division of the 21st Century Act. It lists down the sections of the act which have a direct impact on Healthcare IT and gives a brief overview of each section.This document also explains the impact of 21st Century Cures Act on regulatory bodies: FDA / NIH / HSS.
What you need to know about Meaningful Use 2 & interoperabilityCompliancy Group
Does this describe you?
·You are constantly challenged to stay abreast of the latest information on EHR integration and HIE interoperability, Meaningful Use stages, the Direct Project, clinician and patient portals, just to name a few.
·You walk a fine line between adopting health information technology for the good it can bring patient outcomes…….and for the good incentive dollars it can mean to your organization.
·You play a key role in ensuring your organization can attest for meaningful use.
Join Andy Nieto, Health IT Strategist at DataMotion where he’ll explain the key role that interoperability plays in Meaningful Use Stage 2 attestation including:
- What does interoperability really mean
- Why you can’t ignore interoperability
- How to achieve interoperability and make it meaningful
- What you need in order to attest
Dr Al Mulley: The Secret to Reducing Unwarranted VariationsThe King's Fund
Dr Al Mulley, Director of the Dartmouth Center for Health Care Delivery Science at Dartmouth College, introduces the theory behind good and bad health care variation, looking at the work of Dr Jack Wennberg in the United States.
John Appleby: Health spending in the EU - how does the UK compare?The King's Fund
John Appleby, Chief Economist at The King's Fund, looks at how health spending in the UK compares with other countries and what the prospects are for spending on health care beyond 2015.
International and European Union law Masters programme at RGSLRGSL_lv
Riga Graduate School of Law (RGSL) invites applicants for its Masters programmes.
The core RGSL programme, International and European Union law, covers the fundamental pillars of legal science and theory through specialised tracks that include:
European Union Law
Public International Law and Human Rights
International Commercial Law
Each course track comprises a period of theoretical study and class work, followed by a master’s thesis.
Learn more: www.rgsl.lv
Apply: apply.rgsl.edu.lv
Provenance abstraction for implementing security: Learning Health System and ...Vasa Curcin
Discussion of provenance usage in the Learning Health System paradigm, as implemented in the TRANSFoRm project, with focus on security requirements and how they can be addressed using provenance graph abstraction.
Computer validation of e-source and EHR in clinical trials-KuchinkeWolfgang Kuchinke
Clinical Trials in the Learning Health System (LHS): Computer System Validation of eSource and EHR Data.
The question that was addressed: How to make a clinical trial data management system that uses EHR data, Patient Reported Outcome (PRO) and eSource data as part of the Learning Health System compliant with regulations and with Good Clinical Practice (GCP)?
The Learning Health System (LHS) connects health care with translational and clinical research. It generates new medical knowledge as a by-product of the care process and its aim is to improve health and safety of patients. The LHS generates and applies knowledge. For this purpose, clinical research, which is research involving humans, must be part of the LHS. Two general types of research exists: observational studies and clinical trials.
Clinical data drive the LHS, because results from randomized controlled trials are seen as “gold standard” for medical evidence. For this reason the concept of using data gathered directly from the patient care environment has enormous potential for accelerating the rate at which useful knowledge is generated.
All computer systems involved in clinical trials must undergo Computer System Validation (CSV). For this process, a legal framework for the TRANSFoRm project was developed. It was used for data privacy analysis of the data flow in two research use cases: an epidemiological cohort study on Diabetes and a randomised clinical trial about different GORD treatment regimes.
Computerized system validation is the documented process to produce evidence that a computerized system does exactly what it is designed to do in a consistent and reproducible manner. The validation of electronic source data in clinical trials presents many challenges because of the blurring of the border between care and research. Here we present our approach for the validation of eSource data capture and the developed documentation for the CSV of the complete data flow in the LHS developed by the TRANSFoRm project. An important part hereby played the GORD Valuation Study.
Computer System Validation - privacy zones, eSource and EHR data in clinical ...Wolfgang Kuchinke
Clinical Trials in the Learning Health System (LHS): Computer System Validation of eSource and EHR Data.
The question that was addressed: How to make a clinical trial data management system that uses EHR data, Patient Reported Outcome (PRO) and eSource data as part of the Learning Health System compliant with regulations and with Good Clinical Practice (GCP)?
The Learning Health System (LHS) connects health care with translational and clinical research. It generates new medical knowledge as a by-product of the care process and its aim is to improve health and safety of patients. The LHS generates and applies knowledge. For this purpose, clinical research, which is research involving humans, must be part of the LHS. Two general types of research exists: observational studies and clinical trials.
Clinical data drive the LHS, because results from randomized controlled trials are seen as “gold standard” for medical evidence. For this reason the concept of using data gathered directly from the patient care environment has enormous potential for accelerating the rate at which useful knowledge is generated.
All computer systems involved in clinical trials must undergo Computer System Validation (CSV). For this process, a legal framework for the TRANSFoRm project was developed. It was used for data privacy analysis of the data flow in two research use cases: an epidemiological cohort study on Diabetes and a randomised clinical trial about different GORD treatment regimes.
Computerized system validation is the documented process to produce evidence that a computerized system does exactly what it is designed to do in a consistent and reproducible manner. The validation of electronic source data in clinical trials presents many challenges because of the blurring of the border between care and research. Here we present our approach for the validation of eSource data capture and the developed documentation for the CSV of the complete data flow in the LHS developed by the TRANSFoRm project. An important part hereby played the GORD Valuation Study.
Computer System Validation with privacy zones, e-source and clinical trials b...Wolfgang Kuchinke
Clinical Trials in the Learning Health System: Computer System Validation of eSource and EHR Data. Basic question is how to make a clinical trial data management system that uses EHR data, Patient Reported Outcome (PRO) and eSource data as part of the Learning Health System compliant with regulations and with Good Clinical Practice (GCP)? Computer System Validation (CSV) is a requirement for all computer systems involved in clinical trials for drug submission. It consists of documented processes to produce evidence that a computerized system does exactly what it is designed to do in a consistent and reproducible manner. Validation begins with the system requirements definition and continues until system retirement. For example, the components of a clinical trials
framework used in our case are: Patient eligibility checks and enrolment, pre-population of eCRFs with data from EHRs, PROM data collection by patients, storing of a copy of study data in the EHR, and validation of the Study System that coordinates all study and data collection events.
eSource direct data entry in clinical trials and GCP requirements. It is the duty of physicians who are involved in medical research to protect the privacy and confidentiality of personal information of research subjects. Any eSource system should be fully compliant with the provisions of applicable data protection legislation. This creates the need to develop and implement processes that ensure the continuous control of the investigators over these data. This has to be the focus of CSV. Clinical Data drive the LHS. The results from randomized controlled trials are seen as the “gold standard” for medical evidence, but such trials are often performed outside the usual system of care and recruit highly selected populations. For this reason, the concept of using data gathered directly from the patient care environment has enormous potential for accelerating the rate at which useful knowledge is generated.
This leads to the requirement for validating electronic source data in clinical trials. This includes validation for clinical data that is either captured from the subject directly or from the subject’s medical records. The problem is the correct and appropriate system validation of electronic source data. The main componenets of CSV are the Validation Master Plan), User Requirements Specification, Hardware Requirements Specification, Design qualification, Installation qualification, Operational qualification, Performance qualification.
Any instrument used to capture source data should ensure that the data are captured as specified within the protocol. Source data should be accurate, legible, contemporaneous, original, attributable, complete and consistent. An audit trail should be maintained as part of the source documents for the original creation and subsequent modification of all source data.
Operational research is becoming important in real world setting of health care as it always tried to find out challenges or gaps in any health related issues or in program. For health program improvement, OR should be conducting frequently. Program manager and doctors should be involve in OR and encourage to do so.
Combining Patient Records, Genomic Data and Environmental Data to Enable Tran...Perficient, Inc.
The average academic research organization (ARO) and hospital has many systems that house patient-related information, such as patient records and genomic data. Combining data from a variety of sources in an ongoing manner can enable complex and meaningful querying, reporting and analysis for the purposes of improving patient safety and care, boosting operational efficiency, and supporting personalized medicine initiatives.
In this webinar, Perficient’s Mike Grossman, a director of clinical data warehousing and analytics, and Martin Sizemore, a healthcare strategist, discussed:
-How AROs and hospitals can benefit from a systematic approach to combining data from diverse systems and utilizing a suite of data extraction, reporting, and analytical tools, in order to support a wide variety of needs and requests
-Examples of proposed solutions to real-life challenges AROs and hospitals often encounter
Using real-world evidence to investigate clinical research questionsKarin Verspoor
Adoption of electronic health records to document extensive clinical information brings with it the opportunity to utilise that information to support clinical research, and ultimately to support clinical decision making. In this talk, I discuss both these opportunities and the challenges that we face when working with real-world clinical data, and introduce some of the strategies that we are adopting to make this data more usable, and to extract more value from it. I specifically discuss the use of natural language processing to transform clinical documentation into structured data for this purpose.
NS1450X - Computerized Systems in Clinical ResearchJudson Chase
I am guest lecturer (paid) at the Boston College William F. Connell School of Nursing (more information at http://www.bc.edu/schools/son/aboutus.html).
Three or four times a year I lecture on the application of Computerized Systems in Clinical Research; this is my course deck from 2014.
Challenges and Opportunities Around Integration of Clinical Trials DataCitiusTech
Conducting a Clinical Trial is a complex process, consisting of activities such as protocol preparation, site selection, approval of various authorities, meticulous collection and management of data, analysis and reporting of the data collected
Each activity is benefited from the development of point applications which ease the process of data collection, reporting and decision making. The recent advancements in mobile technologies and connectivity has enabled the generation and exchange of a lot more data than previously anticipated. However, the lack of interoperability and proper planning to leverage this data, still acts as a roadblock in allowing organizations truly harness their data assets. This document will help life sciences IT professionals and decision makers understand challenges and opportunities around clinical data integration
Clinical trial data wants to be free: Lessons from the ImmPort Immunology Dat...Barry Smith
Presentation to the Clinical and Research Ethics Seminar, Clinical and Translational Science Center, Buffalo, January 21, 2014
https://immport.niaid.nih.gov/
http://youtu.be/booqxkpvJMg
Similar to Brendan Delany – Chair in Medical Informatics and Decision Making, Imperial College (20)
Personalising care across a whole pathway leads to more precise treatment regimes, better outcomes and greater resource efficiency. In this session we will demonstrate how by applying technology to various stages of the anti-coagulation we can achieve greater health gain at lower costs.
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Brendan Delany – Chair in Medical Informatics and Decision Making, Imperial College
1. EU Projects and The Learning Health
System.
Brendan Delaney
Chair in Medical Informatics and Decision Making
Director Centre for Patient Safety and Service Quality
Imperial College London
2. What is a ‘Learning Health System’?
‘A learning healthcare system is [one that] is designed
to generate and apply the best evidence for the
collaborative healthcare choices of each patient and
provider; to drive the process of discovery as a natural
outgrowth of patient care; and to ensure innovation,
quality, safety, and value in health care.’
Institute of Medicine. 2007
3. www.transformproject.eu
€7.5M European Commission
March 2010-Nov 2015
Funded under the Patient Safety Work Program of FP7
• To support clinical diagnosis
• To support clinical trials
• As part of a ‘Rapid Learning Healthcare System’
3
5. Aims of TRANSFoRm
To develop methods, models, services, validated
architectures and demonstrations to support THE
LEARNING HEALTH SYSTEM:
•Epidemiological research using primary care records,
including genotype-phenotype studies and other record
linkages
•Research workflow embedded in the EHR
•Decision support for diagnosis
6. TRANSFoRm clinical requirements (2010-15)
Part of a Learning Health System
Prevalent and incident case identification from live EHR
systems in primary care
Real time alerting via EHR
Pre-population of CRFs displayed “within” the EHR
Data capture in EHR (eSource)
PROMS data in EHR for Safety monitoring
Data provenance – towards compliance with 21 CFR
Part 11 and European regulation
Full evaluation in 5 EU member states and real world
RCT
7. TRANSFoRm technical requirements
To use ontologies to maintain models of meaning for
the LHS (CRIM, CDIM, Provenance)
To use CDISC foundational standards ODM, SDM
To enable connection to multiple country, multiple
language, multiple vendor systems with MINIMAL
vendor input – No ‘hackathons’
Vendor requirements:
• Standard Terminology used in EHR (LexEVS)
• Sample EHR data set
• Represent local database metadata as a model (DSM) and
map to TRANSFoRm Clinical Data Integration Model
(ontology)
• API and a demo installation for testing
8. Limitations of existing CDISC standards for clinical trials
Operational Data Model operates as a holder and can
contain a wide variety of content.
Therefore clinical meaning and context can vary between
clinical and research domains in unpredictable ways.
CDASH offers a means of assembling libraries of well-
defined forms, but does not implicitly translate to a
clinical setting
8
9. Approach to Meaning
TRANSFoRm uses common data models expressed as
ONTOLOGIES to maintain meaning across the
Learning Health System
Archetypes are used to link ‘meaning’ as a reference to
the ontologies (Research and clinical meaning) at
individual data element level
9
10. A software platform for the Learning Health
System is built using tools to author,
exchange and act upon these basic
information constructs. It serves all three use
cases.
10
11. Four points of eCRF/EHR integration
1. Extracting study data from the EHR to facilitate data
entry
2. Asking physician to complete the study data that are
not present in the eHR
3. Presenting all study data to the physician for approval
before sending to the research databasein order to
increase control and data quality
4. Adding care-relevant study data to the EHR, so that the
physician needs to fill out the information only once
17. User Interface Extension to ODM
ODM extended with GUI elements
When an ODM is created, the QuestionType attribute is added to every
ItemDef object in ODM
Platform-agnostic, rendered appropriately for each device
20. The power of early hypotheses
Hypotheses formulated quickly and with little information.1
Disproportionate influence of early hypotheses on subsequent
judgements and decisions.2-4
Strong association between physicians’ initial diagnostic
impressions and their final diagnoses (and management) in
common presentations that could indicate cancer.5
Baron (2000);1
Asch (1946);2
Crano (1977);3
Forgas
(2011);4
Kostopoulou, Sirota et al MDM 2016 5
21. The principle of early diagnostic support
• Suggest possible diagnoses early in the consultation,
before physicians start gathering information to test their own
hypotheses.
• Diagnostic suggestions based on patient’s age, sex, risk
factors and reason for encounter (RfE).
• Principle tested in 2 RCTs: UK1
and Greece2
(D2.1)
• Online, interactive, simulated consultations with 9 clinical
scenarios
26. DSS prototype evaluation in a high-fidelity simulation
• 34 GPs – users of Vision EHR system
• 12 standardised patients (actors)
• 2 sessions (within-participant design)
» 1st
session: (baseline performance) Vision EHR – no DSS.
» 2nd
session: Vision EHR with integrated DSS.
27.
28. Results
MEASURE
Baseline
Mean [95% CIs]
DSS
Mean [95% CIs]
Odds ratios or
stand. coefficients
[95% CIs]
Diagnostic
accuracy
0.50
[0.42 to 0.57]
0.58
[0.52 to 0.65]
OR 1.41
[1.13 to 1.77],
P<0.01
Appropriate
management
0.59
[0.52 to 0.66]
0.66
[0.52 to 0.65]
OR 1.34
[1.01 to 1.78],
P<0.05
Diagnostic
certainty (0-10
VAS)
7.61
[7.28 to 7.94]
8.01
[7.79 to 8.23]
Beta 0.39
[0.12 to 0.67],
P<0.01
Data items coded
into the EHR
1.64
[1.10 to 2.18]
12.35
[10.82 to 13.87]
Beta 10.71
[9.06 to 12.35],
P<0.01
95% CIs are adjusted for clustering on GP
29. Results
MEASURE
Baseline
Mean [95% CIs]
DSS
Mean [95% CIs]
Standardised
coefficients
[95% CIs]
Investigations
ordered
2.51
[1.92 to 3.09]
2.83
[2.33 to 3.33]
Beta 0.33
[-0.54 to 1.20]
Consultation length
(mins)
13.73
[12.61 to 14.85]
14.42
[13.05 to 15.79]
Beta 0.69
[-0.28 to 1.67]
Patient satisfaction
(5-point Likert)
3.26
[3.07 to 3.45]
3.26
[3.10 to 3.42]
Beta 0.001
[-0.18 to 0.18]
33. Conclusions
• Improvement in diagnoses and decisions
• Without more investigations ordered/time taken
• A lot more data coded into the EHR
• GPs recorded during the consultation (not at the end)
• Opportunity to capture rich (and less biased) routine
data
• A Learning Health System for diagnosis
We shall look into the mechanism behind the first one
The diagnoses in the list are ordered according to published UK incidence rates:
common (&gt; 50/100,000 p/a),
uncommon (10/100,000 to 50/100,000 p/a), and
rare (&lt;10/100,000 p/a).
Within each category of incidence, the diagnoses are ordered randomly.
Patient age ranged from 22 to 70
Importance of terminologies – but need to be flexible
Code Binding – Need for reference terminology
Synonym – Need for local terminology