1) Doctors are open to using patient-generated health data from fitness trackers and connected devices to inform diagnostic decisions, and many want this data integrated into electronic medical records.
2) Data handling and security is a major concern for doctors, as is establishing defined and certified technical standards for connected health devices.
3) Doctors see potential for patient data to be harnessed in multiple ways, such as reducing unnecessary emergency room visits through remote monitoring of chronic conditions.
Medisafe_What's Next in RWE_mHealth IsraelLevi Shapiro
Presentation by Medisafe CEO, Omri Shor, Oct 19, 2021, for the mHealth Israel community.
- Medisafe’s Patient Engagement Platform
- Real World Evidence: Economic Impact for Pharma
- Connecting Pharma to patients
- Case Study: Supporting Patients through Digital Platform
-
Patients recognize the benefits of technology-enhanced care, yet only 1 out of 10 use remote patient monitoring today. Read three keys to adoption. https://accntu.re/3fnEy6r
Paul Coplan, VP, Johnson & Johnson_mHealth IsraelLevi Shapiro
Pesentation, October 19th, 2021: What’s Next in RWE for Medical Devices: The Art of the Possible. Presented by Paul Coplan, ScD, MBA, FISPE, Vice President, Med Device Epidemiology and RWD Sciences, Johnson & Johnson; Adjunct Professor, Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania, Perelman School of Medicine; Fellow of the International Society of Pharmacoepidemiology
- Why RWE is Important for Medical Devices: Challenges with Clinical Trials of Medical Devices (Blinding, Surgeon skill/technique, Hospital process, Product modifications, Long term Follow up, Enrolment challenges)
- Types of Real-World Data Sources (Complaints like MAUDE, Eudramed and Company Databases, Hospital Databases, Electronic Health Records, Claims, Registries, Patient surveys, Surgeon surveys, PROs, Patient Preferences, wearables, sensors, social media, Surgical videos, device generated data, radiographic images)
- FDA CDRH Report on RWE Examples for Regulatory Decisions
- J&J Med Device Epidemiology & Real-World Data Sciences
- US National Evaluation System for Health Technology (NEST)
- RWE for Safety Assessments: Cobalt in Implants and at Work and Risk of Cancer
- Summary of Cobalt Exposure and All-Site Cancer Risk, by Study Type
- Comparative Effectiveness Studies Using RWE
- Summary
a. Use of RWE is important to benefit patients globally and enhance the safety and innovation of medical devices
b. Regulators are interested in using RWE for regulatory decisions but data quality and evidence needs to be regulatory grade
c. NEST has been a useful forum to advance the use of RWE for regulatory decisions in the US
d. RWE can be used for safety assessments, regulatory decisions, comparative effectiveness research, and R&D of products
Medisafe_What's Next in RWE_mHealth IsraelLevi Shapiro
Presentation by Medisafe CEO, Omri Shor, Oct 19, 2021, for the mHealth Israel community.
- Medisafe’s Patient Engagement Platform
- Real World Evidence: Economic Impact for Pharma
- Connecting Pharma to patients
- Case Study: Supporting Patients through Digital Platform
-
Patients recognize the benefits of technology-enhanced care, yet only 1 out of 10 use remote patient monitoring today. Read three keys to adoption. https://accntu.re/3fnEy6r
Paul Coplan, VP, Johnson & Johnson_mHealth IsraelLevi Shapiro
Pesentation, October 19th, 2021: What’s Next in RWE for Medical Devices: The Art of the Possible. Presented by Paul Coplan, ScD, MBA, FISPE, Vice President, Med Device Epidemiology and RWD Sciences, Johnson & Johnson; Adjunct Professor, Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania, Perelman School of Medicine; Fellow of the International Society of Pharmacoepidemiology
- Why RWE is Important for Medical Devices: Challenges with Clinical Trials of Medical Devices (Blinding, Surgeon skill/technique, Hospital process, Product modifications, Long term Follow up, Enrolment challenges)
- Types of Real-World Data Sources (Complaints like MAUDE, Eudramed and Company Databases, Hospital Databases, Electronic Health Records, Claims, Registries, Patient surveys, Surgeon surveys, PROs, Patient Preferences, wearables, sensors, social media, Surgical videos, device generated data, radiographic images)
- FDA CDRH Report on RWE Examples for Regulatory Decisions
- J&J Med Device Epidemiology & Real-World Data Sciences
- US National Evaluation System for Health Technology (NEST)
- RWE for Safety Assessments: Cobalt in Implants and at Work and Risk of Cancer
- Summary of Cobalt Exposure and All-Site Cancer Risk, by Study Type
- Comparative Effectiveness Studies Using RWE
- Summary
a. Use of RWE is important to benefit patients globally and enhance the safety and innovation of medical devices
b. Regulators are interested in using RWE for regulatory decisions but data quality and evidence needs to be regulatory grade
c. NEST has been a useful forum to advance the use of RWE for regulatory decisions in the US
d. RWE can be used for safety assessments, regulatory decisions, comparative effectiveness research, and R&D of products
What's Next in RWE_Amy Rudolph_Novartis_mHealth IsraelLevi Shapiro
Overview of the
- Healthcare ecosystem complexity increasing rapidly
- Pharma industry is facing a crisis: trends shaping the industry
- RWE complements RCTs and captures implementation of innovation
- RWE is one component of the integrated evidence needed for stakeholders
- Integrated Evidence: Optimizing patient access
- Integrated Evidence: Label expansion
- Maximizing the value of data requires a scalable platform and expertise
Patient Centricity: EHR Pillars to Patient CentricityDayOne
AT the DayOne Experts - Next Generation Clinical Trials, Randy Ramin-Wright from Clinerion demonstrated how patient recruitment works in the digital age.
Closed Loop Medication Management - A preferred way to go go forward for Prov...CitiusTech
Closed Loop Medication Management (CLMM) system is a fully electronic medication management process that integrates automated and intelligent systems to completely close the inpatient medication management and administration loop, and seamlessly document all the relevant information.
AMCCBS Virtual2021 Conference Takeaways Part 2Carevive
Check out Debra Wujcik's takeaways from her presentation at #AMCCBSVirtual. She talked about the benefits and crucial data that can be harnessed when using Remote Symptom Monitoring and ePRO platforms.
What's Next in RWE_Amy Rudolph_Novartis_mHealth IsraelLevi Shapiro
Overview of the
- Healthcare ecosystem complexity increasing rapidly
- Pharma industry is facing a crisis: trends shaping the industry
- RWE complements RCTs and captures implementation of innovation
- RWE is one component of the integrated evidence needed for stakeholders
- Integrated Evidence: Optimizing patient access
- Integrated Evidence: Label expansion
- Maximizing the value of data requires a scalable platform and expertise
Patient Centricity: EHR Pillars to Patient CentricityDayOne
AT the DayOne Experts - Next Generation Clinical Trials, Randy Ramin-Wright from Clinerion demonstrated how patient recruitment works in the digital age.
Closed Loop Medication Management - A preferred way to go go forward for Prov...CitiusTech
Closed Loop Medication Management (CLMM) system is a fully electronic medication management process that integrates automated and intelligent systems to completely close the inpatient medication management and administration loop, and seamlessly document all the relevant information.
AMCCBS Virtual2021 Conference Takeaways Part 2Carevive
Check out Debra Wujcik's takeaways from her presentation at #AMCCBSVirtual. She talked about the benefits and crucial data that can be harnessed when using Remote Symptom Monitoring and ePRO platforms.
Top Brainnovation to improve Brain Health & PerformanceSharpBrains
The three Finalists were:
*Click Therapeutics — pitch by David Klein, Co-Founder & CEO
*AUGMENTx (WINNER) — pitch by Dr. Albert Kwon, Co-Founder & CEO
*Sincrolab — pitch by Ignacio de Ramon, Co-Founder & CEO
*Judged by: Alexandra Morehouse, Chief Marketing Officer at Banner Health; Colin Milner, Founder and CEO of the International Council on Active Aging (ICAA); Danny Dankner, CEO and Co-founder of Applied Cognitive Engineering; Zack Lynch, General Partner at JAZZ Venture Partners
*Álvaro Fernández, CEO and Editor-in-Chief of SharpBrains
*Sarah Lenz Lock, Senior Vice President for Policy at AARP and Executive Director of the Global Council on Brain Health (GCBH)
*Dr. April Benasich, Director of the Baby Lab at the Rutgers Center for Molecular and Behavioral Neuroscience
*Chaired by: Dr. Cori Lathan, Co-Chair of the World Economic Forum’s Council on the Future of Human Enhancement
Slidedeck supporting session held during the 2017 SharpBrains Virtual Summit: Brain Health & Enhancement in the Digital Age (December 5-7th). Learn more at: https://sharpbrains.com/summit-2017/
Protocols and Evidence based Healthcare: information technology tools to support best practices in health care, information technology tools that inform and empower patients.
Taking the Physician's Pulse on Cybersecurityaccenture
Accenture and the American Medical Association (AMA) surveyed U.S. physicians regarding their experiences and attitudes toward cybersecurity. The findings suggest a strong need for improved cybersecurity education for physicians.
Chapter 4 Electronic Health RecordsRobert Hoyt MDVishnu Moh.docxrobertad6
Chapter 4: Electronic Health Records
Robert Hoyt MD
Vishnu Mohan MD
After reading this chapter the reader should be able to:
State the definition and history of electronic health records (EHRs)
Describe the limitations of paper-based health records
Identify the benefits of electronic health records
List the key components of an electronic health record
Describe the ARRA-HITECH programs to support EHRs
Describe the benefits and challenges of computerized order entry and clinical decision support systems
State the obstacles to purchasing, adopting and implementing an electronic health record
Enumerate the steps to adopt and implement an EHR
Learning Objectives
2
There is no topic in health informatics as important, yet controversial, as the electronic health record (EHR)
In spite of fledgling EHRs being around for the past 35-40 years they are still controversial in the eyes of many
Due to the federal government reimbursement programs for EHR use by physicians and hospitals, EHRs are now part of the healthcare landscape
Some of the famous early EHRs are listed on the next slide
Introduction
The Problem Oriented Medical Information System (PROMIS)
American Rheumatism Association Medical Information System (ARAMIS)
Regenstrief Medical Record System (RMRS)
Summary Time Oriented Record (STOR)
Health Evaluation Through Logical Processing (HELP)
Computer Stored Ambulatory Record (COSTAR)
De-Centralized Hospital Computer Program (DHCP)—forerunner of VistA (Veterans Health Administration)
Early EHRs
Electronic Health Record: “An electronic record of health-related information on an individual that conforms to nationally recognized interoperability standards and that can be created, managed and consulted by authorized clinicians and staff across more than one healthcare organization”
While the “experts” can debate the difference between EHR and EMR, we will not and will stick with EHR throughout the textbook and slides
Definition
Paper records are severely limited: less legible, more difficult to retrieve, store and share and unstructured data. Also, electronic records less likely to be missing and available 24/7 from multiple locations. Paper records do not permit clinical decision support
Need for improved efficiency and productivity: clinicians are more productive if charts are available and retrieval of results is faster. EHR access from home while on call helps productivity
Quality of care and patient safety: the factors already described in last two bullets plus clinical decision support, quality reports and secure messaging as part of an EHR
Why do we need EHRs?
Public expectations: EHRs may increase patient satisfaction through faster results, messaging, patient portals, electronic patient education, e-prescribing and online scheduling
Governmental expectations: federal government considers EHR to be transformational and hence why they support reimbursement for u.
We are truly on the edge of a new and exciting era. Here are the top five ways AI is revolutionizing healthcare and what could be in store over the coming years.
Can new technologies like artificial intelligence, wearables and digital therapeutics transform healthcare? Rapid changes in new technology show promise to move healthcare forward and improve efficiency.
The 2016 - 2020 strategy for the Personal Connected Health Alliance defines the field of personal connected health to provide one common definition and reviews the scope of this space, its market insights and more. Utilize this presentation to understand PCHAlliance's vision of personal connected health's strategic role and how we aim in pursuing this potential.
Personal connected health is currently characterized by limited thought leadership, insufficient coordination and collaboration, and a lack of awareness and understanding of the full potential by all stakeholders: public, providers, policymakers, industry and patients. The Personal Connected Health Alliance is defining the the field of personal connected health to inspire market and policy innovation, research and collective action for sustained adoption of personal connected health technology. The vision is better health and well being for all through increased personal responsibilities and connectivity as well as improved care delivery enabled by technology.
What hope do social networks offer the future of person-centered health? Tune in to see one disruptive woman’s vision for social network- driven wellness, Jen Hyatt, CEO, Big White Wall.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
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
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
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
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
Title: Sense of Smell
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 primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
2. 2
Many doctors believe that PCH devices are helping health outcomes but
more convincing to be done
Base: UK&US (n=256)
Q2. To what extent do you agree, on a scale of 1 to 7, that your patients’ use of fitness trackers, and other personal connected health
devices, is helping to improve their health outcomes?
59% 41%
35%
52%
1 in 3 Doctors believe
that personal connected
health devices are
helping to improve their
patients health
outcomes (T2B)
Over half of doctors are
only moderately
convinced. Substantial
opportunity to drive
market (M2B)
3. 3
Doctors are open to use patient generated data to inform diagnostic decisions, many of which would
like to have it included into EMR systems
Base: UK&US (n=256)
Q3. How likely are you, on a scale of 1 to 7, to use data generated by your patients (through the use of fitness trackers and other personal connected
devices) to inform your diagnostic decision making?
Q4. To what extent do you agree, on a scale of 1 to 7, that you would like Electronic medical record (EMR) providers to integrate patient generated data
(from fitness trackers and other personal connected devices) into EMR systems and workflows?
26%
29%
Doctors are generally open to using data
generated through fitness trackers to
inform diagnostic decisions. 45% (M2B)
however are currently moderately likely
to use such data.
(T2B)
(B3B)
39% of doctors strongly
agree that patient generated data
should be included in EMR systems
(T2B)
37% of doctors
moderately agree (M2B)
4. 4
Data handling and security is a major concern along with the
importance of defined and certified technical standards
Base: UK&US (n=256)
Q5. How much of a concern is the issue of data handling and security in relation to patient generated data to you?
Q6. In your opinion, how important are defined and certified technical standards for personal connected health devices?
58% of doctors are
concerned/ very concerned about how
patient data is handled and secured
(T3B). Reassurance is key.
78% find defined and
certified technical standards important/
very important (T3B)
5. 5
Patient generated data can be harnessed in multiple ways
Base: UK&US (n=256)
Q8. To what extent do you agree, on a scale of 1 to 7, remote monitoring of chronic conditions can reduce unnecessary emergency room visits or re-
hospitalization?
Q9. To what extent do you agree, one a scale of 1 – 7, that patient-generated data (captured by fitness trackers and other personal connected health
devices) can be used to replace more formal data collection processes in clinical trials?
41% strongly agree that
remote monitoring of chronic conditions
can reduce unnecessary emergency
room visits.
25% of doctors believe
patient generated data can be used to
replace more formal data collection
processes in clinical trials (T2B)