Rising Importance of Health Economics & Outcomes ResearchCitiusTech
Health Economics & Outcomes Research (HE&OR) guides stakeholders to make informed decisions regarding patient access to drugs and services. This document highlights specific use cases for healthcare information technology that add value to HE&OR.
Decentralized Monitoring in Clinical TrialsClinosolIndia
Decentralized monitoring in clinical trials refers to a modern approach to monitoring the progress, safety, and data integrity of clinical trials using remote and technology-driven methods. Traditional clinical trial monitoring involves frequent on-site visits by monitors to ensure that the trial is conducted according to the protocol and regulatory requirements. However, this approach can be resource-intensive, time-consuming, and may not always provide real-time insights.
Decentralized monitoring leverages technology, data analytics, and remote communication tools to monitor various aspects of clinical trials. Here are some key components of decentralized monitoring:
Risk Based Monitoring in Clinical Trials.ClinosolIndia
Risk-based monitoring (RBM) is a monitoring strategy in clinical trials that aims to improve the quality and efficiency of data collection while reducing costs and burden on study participants. Rather than conducting monitoring activities at fixed intervals, RBM utilizes a risk assessment approach to identify areas of the study that are at higher risk of errors or deviations from the protocol and focuses monitoring efforts on those areas.
The RBM process begins with a risk assessment, which involves identifying potential risks to the study's data integrity, participant safety, and study conduct. This may include risks related to patient enrollment, data collection, adverse event reporting, or protocol compliance. Based on the risk assessment, the study team creates a risk management plan that outlines the monitoring strategy to be employed throughout the trial.
In RBM, monitoring activities are targeted to focus on the areas of the study that present the highest risk. For example, if a study has a high risk of data entry errors, the monitoring plan may include a more intensive review of data entry activities or require that data be entered in real-time, so errors can be identified and corrected more quickly.
RBM can be facilitated through several tools, such as centralized monitoring, key risk indicator (KRI) dashboards, or data analytics. Centralized monitoring allows for remote review of study data by a team of experts who can identify trends and issues more efficiently. KRIs are pre-defined metrics used to track performance and detect areas of concern, allowing for proactive management of risks. Data analytics can identify unusual patterns or outliers in the data, enabling the study team to focus on those areas of concern.
RBM is a dynamic process that involves ongoing evaluation of the study's risk profile and adjusting the monitoring strategy accordingly. By focusing monitoring efforts on the areas of the study that pose the highest risk, RBM can improve data quality and participant safety, while reducing monitoring costs and burden.
Healthcare’s Labor Challenge – Why is it Happening and What Can You do About It?Health Catalyst
Soaring labor costs and workforce shortages are wreaking havoc on health system financials and impacting patient care. We will discuss how we got to this point and what health systems can do in the short-term to combat these headwinds while building a happier and more sustainable workforce in the future.
Patient recruitment & retention is highlighted as the key factor in ensuring study success, the area of patient retention in clinical trials is often overlooked. Retention of patients throughout the life of a clinical trial is however extremely vital from scientific as well as economic point of view. Poor recruitment & retention negatively impacts on the overall evaluable data for regulatory submissions. Dropped participants must be replaced which incurs further expenditures and time delays. Subject dropout rates are estimated to range from 15-40% of enrolled participants in clinical trials.
Rising Importance of Health Economics & Outcomes ResearchCitiusTech
Health Economics & Outcomes Research (HE&OR) guides stakeholders to make informed decisions regarding patient access to drugs and services. This document highlights specific use cases for healthcare information technology that add value to HE&OR.
Decentralized Monitoring in Clinical TrialsClinosolIndia
Decentralized monitoring in clinical trials refers to a modern approach to monitoring the progress, safety, and data integrity of clinical trials using remote and technology-driven methods. Traditional clinical trial monitoring involves frequent on-site visits by monitors to ensure that the trial is conducted according to the protocol and regulatory requirements. However, this approach can be resource-intensive, time-consuming, and may not always provide real-time insights.
Decentralized monitoring leverages technology, data analytics, and remote communication tools to monitor various aspects of clinical trials. Here are some key components of decentralized monitoring:
Risk Based Monitoring in Clinical Trials.ClinosolIndia
Risk-based monitoring (RBM) is a monitoring strategy in clinical trials that aims to improve the quality and efficiency of data collection while reducing costs and burden on study participants. Rather than conducting monitoring activities at fixed intervals, RBM utilizes a risk assessment approach to identify areas of the study that are at higher risk of errors or deviations from the protocol and focuses monitoring efforts on those areas.
The RBM process begins with a risk assessment, which involves identifying potential risks to the study's data integrity, participant safety, and study conduct. This may include risks related to patient enrollment, data collection, adverse event reporting, or protocol compliance. Based on the risk assessment, the study team creates a risk management plan that outlines the monitoring strategy to be employed throughout the trial.
In RBM, monitoring activities are targeted to focus on the areas of the study that present the highest risk. For example, if a study has a high risk of data entry errors, the monitoring plan may include a more intensive review of data entry activities or require that data be entered in real-time, so errors can be identified and corrected more quickly.
RBM can be facilitated through several tools, such as centralized monitoring, key risk indicator (KRI) dashboards, or data analytics. Centralized monitoring allows for remote review of study data by a team of experts who can identify trends and issues more efficiently. KRIs are pre-defined metrics used to track performance and detect areas of concern, allowing for proactive management of risks. Data analytics can identify unusual patterns or outliers in the data, enabling the study team to focus on those areas of concern.
RBM is a dynamic process that involves ongoing evaluation of the study's risk profile and adjusting the monitoring strategy accordingly. By focusing monitoring efforts on the areas of the study that pose the highest risk, RBM can improve data quality and participant safety, while reducing monitoring costs and burden.
Healthcare’s Labor Challenge – Why is it Happening and What Can You do About It?Health Catalyst
Soaring labor costs and workforce shortages are wreaking havoc on health system financials and impacting patient care. We will discuss how we got to this point and what health systems can do in the short-term to combat these headwinds while building a happier and more sustainable workforce in the future.
Patient recruitment & retention is highlighted as the key factor in ensuring study success, the area of patient retention in clinical trials is often overlooked. Retention of patients throughout the life of a clinical trial is however extremely vital from scientific as well as economic point of view. Poor recruitment & retention negatively impacts on the overall evaluable data for regulatory submissions. Dropped participants must be replaced which incurs further expenditures and time delays. Subject dropout rates are estimated to range from 15-40% of enrolled participants in clinical trials.
How to Structure the “Approach” Section of a Grant Application by David Elash...UCLA CTSI
David Elashoff, PhD speaks on the topic of "How to Structure the “Approach” Section of a Grant Application" at the November 09, 2017 R Award Workshop at UCLA.
Compliance with the FDA Guidances on Investigator Responsibilities and the Fo...Paul Below
This presentation was given at the North Texas Chapter ACRP Research Symposium, Dallas, TX (Aug 2011) and the SoCRA 20th Annual Conference, San Diego, CA (Sep 2011).
TSDP tells about the essential documents that are required for the #conduct of a clinical trial. For #regulatory medical writing training, contact hello@turacoz.in.
Coffee is one of the most traded commodity in the world, next only to oil. Undeniably, it is the most favorite beverage of the people. It is so irresistible that large section of people are addicted to it. Often, this addiction is seen in negative light and considered hazardous to one's health.
Come discover the amazing health benefits of being addicted to coffee. It is nothing less than miraculous.
20+ good health reasons to drink coffee2abdunatfah
There are good reasons to drink coffee and there are a few reasons not to. This article is for those that are looking for reasons to keep drinking it.
After all, you may have a caffeine-hater in your life. You know the type – they’re always telling you what’s bad for your health.
20+ good health reasons to drink coffee2
Here’s a list of some good reasons to drink coffee. Memorize this list – so the next time you encounter your favorite coffee-hater you can pull out one of these babies
Drinking Coffee Does Not Damage Your Heart
http://buyorganiccoffee.org/1589/drinking-coffee-does-not-damage-your-heart/
There are cardiovascular benefits to drinking coffee so drink up according to an article published in the New York Post.
Researchers from the University of California San Francisco looked at 1,388 people who were taking part in a larger heart study, specifically 60 percent of group who said drinking caffeinated drinks - coffee, tea and chocolate - were part of their daily routine.
The researchers looked for heart irregularities - premature ventricular and atrial contractions - in the participants over a year, but found that there were no differences among the participants, average age 72, regardless of their caffeine intake.
Their findings go against the conventional clinical knowledge in the medical world that caffeine causes palpitations, which can lead to more chronic problems including heart failure or arrhythmias.
In fact, they discovered that “habitual coffee drinkers” actually have less of a chance of developing coronary artery disease.
This is another addition to the list of benefits of coffee, especially organic coffee.
How to Structure the “Approach” Section of a Grant Application by David Elash...UCLA CTSI
David Elashoff, PhD speaks on the topic of "How to Structure the “Approach” Section of a Grant Application" at the November 09, 2017 R Award Workshop at UCLA.
Compliance with the FDA Guidances on Investigator Responsibilities and the Fo...Paul Below
This presentation was given at the North Texas Chapter ACRP Research Symposium, Dallas, TX (Aug 2011) and the SoCRA 20th Annual Conference, San Diego, CA (Sep 2011).
TSDP tells about the essential documents that are required for the #conduct of a clinical trial. For #regulatory medical writing training, contact hello@turacoz.in.
Coffee is one of the most traded commodity in the world, next only to oil. Undeniably, it is the most favorite beverage of the people. It is so irresistible that large section of people are addicted to it. Often, this addiction is seen in negative light and considered hazardous to one's health.
Come discover the amazing health benefits of being addicted to coffee. It is nothing less than miraculous.
20+ good health reasons to drink coffee2abdunatfah
There are good reasons to drink coffee and there are a few reasons not to. This article is for those that are looking for reasons to keep drinking it.
After all, you may have a caffeine-hater in your life. You know the type – they’re always telling you what’s bad for your health.
20+ good health reasons to drink coffee2
Here’s a list of some good reasons to drink coffee. Memorize this list – so the next time you encounter your favorite coffee-hater you can pull out one of these babies
Drinking Coffee Does Not Damage Your Heart
http://buyorganiccoffee.org/1589/drinking-coffee-does-not-damage-your-heart/
There are cardiovascular benefits to drinking coffee so drink up according to an article published in the New York Post.
Researchers from the University of California San Francisco looked at 1,388 people who were taking part in a larger heart study, specifically 60 percent of group who said drinking caffeinated drinks - coffee, tea and chocolate - were part of their daily routine.
The researchers looked for heart irregularities - premature ventricular and atrial contractions - in the participants over a year, but found that there were no differences among the participants, average age 72, regardless of their caffeine intake.
Their findings go against the conventional clinical knowledge in the medical world that caffeine causes palpitations, which can lead to more chronic problems including heart failure or arrhythmias.
In fact, they discovered that “habitual coffee drinkers” actually have less of a chance of developing coronary artery disease.
This is another addition to the list of benefits of coffee, especially organic coffee.
Is it advisable to drink coffee when you have a ‘heart condition’? Does drinking
coffee have any influence on the occurrence and development of cardiovascular
disease? People used to think so. But what is the current advice? Heavy coffee
drinkers are quite often also heavy smokers. For instance, in one of the first
studies in this field the relationship between drinking coffee and cardiovascular
disease could be wholly attributed to the fact that coffee drinkers had been
smoking more (Katan, 1994). More recent studies, have adjusted for ‘other’
factors that could influence the results.
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.
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
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
263778731218 Abortion Clinic /Pills In Harare ,sisternakatoto
263778731218 Abortion Clinic /Pills In Harare ,ABORTION WOMEN’S CLINIC +27730423979 IN women clinic we believe that every woman should be able to make choices in her pregnancy. Our job is to provide compassionate care, safety,affordable and confidential services. That’s why we have won the trust from all generations of women all over the world. we use non surgical method(Abortion pills) to terminate…Dr.LISA +27730423979women Clinic is committed to providing the highest quality of obstetrical and gynecological care to women of all ages. Our dedicated staff aim to treat each patient and her health concerns with compassion and respect.Our dedicated group ABORTION WOMEN’S CLINIC +27730423979 IN women clinic we believe that every woman should be able to make choices in her pregnancy. Our job is to provide compassionate care, safety,affordable and confidential services. That’s why we have won the trust from all generations of women all over the world. we use non surgical method(Abortion pills) to terminate…Dr.LISA +27730423979women Clinic is committed to providing the highest quality of obstetrical and gynecological care to women of all ages. Our dedicated staff aim to treat each patient and her health concerns with compassion and respect.Our dedicated group of receptionists, nurses, and physicians have worked together as a teamof receptionists, nurses, and physicians have worked together as a team wwww.lisywomensclinic.co.za/
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
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
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.
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.
Coffee / Health Myths and Facts: Why We Need a Risk-Benefit “Holistic” Approach for Carcinogens” Coughlin
1. Coffee / Health Myths and Facts: Why We
Need a Risk-Benefit “Holistic” Approach
for Carcinogens”
James R. Coughlin, Ph.D.
President, Coughlin & Associates
Aliso Viejo, California
jrcoughlin@cox.net
www.linkedin.com/in/jamescoughlin
Pacific Coast Coffee Association
82nd Annual Convention
Aptos, California
September 20, 2013
2. Presentation Outline
Coffee / Health Myths & Facts: 30+ Year History
Acrylamide Background
– Animal Carcinogenicity
– Human Epidemiologic Evidence
Heat-produced Carcinogens in Foods
California Proposition 65 and Acrylamide
Benefit-Risk Evaluation of Coffee
– The “Holistic Approach”
– The “Coffee-Cancer Paradox”
2
3. A 30+ Year Coffee/Health Perspective
…on Rats, Mice and Humans
…on “Good” and “Bad” Science
…on “Good” and “Bad” Media Coverage
…on Coffee’s Beneficial Health Effects
…on “Holistic” Risk-Benefit Evaluation
3
4. Coffee / Health Conclusions:
1980 - 2013
… First 20 Years:
Mostly Bad News! Coffee and Caffeine
were linked to almost every known animal
and human disease!
… Last 15 Years, a Big Turn Around:
The “Good News” is that almost all of
the Bad News was WRONG!
4
5. Why have Coffee/Caffeine been so maligned?
•
Dramatically increased interest in health and nutrition;
much consumer worry about enjoying too much of a
good thing!
•
What we eat…or don’t eat…is always being linked to
disease, and there is so much Consumer Anxiety from
dietary headlines
•
AVOID or REDUCE: salt, fat (fries and chips), red meat,
carbs, soft drinks, coffee and caffeine!!
5
7. What Science Allowed the Bad Myths to
Happen and Why Do a Few Still Persist?
… Acute vs. Chronic effects:
Partial / full tolerance to caffeine develops in humans
consistently consuming caffeine and coffee daily
… Most of the Myths and Fears are based on:
Acute effects testing of non-coffee consuming subjects
Massive doses of individual coffee chemicals fed to
animals for a lifetime
Smaller poorly done human studies.
7
8. Much Confusion over Coffee and Caffeine
“Perhaps no substance has been the subject of
more conflicting media and scientific reports in
recent years than caffeine. So, is a cup of coffee
bad for you or not?”
Los Angeles Times, September 11-13, 1994 risk series
- But no one was even asking back then “So, is a cup of coffee good for you or not?”
8
9. But since 2000 or so…
The “Good News” is that almost all of the
earlier Bad News about Coffee was WRONG!
Medical evidence has been building strongly
that coffee may actually be GOOD for us!!!
Let’s briefly examine the evidence for some
myths and facts…
9
10. The “Maligning” Started in the Late 1970’s
and Ballooned in the 1980’s and Early 1990’s
•
Coffee and heart attacks
•
Coffee and bladder & pancreatic cancer
•
Caffeine and birth defects in rats (U.S. FDA, 1978)
•
Caffeine and osteoporosis
•
Caffeine “Addiction”
10
12. Coffee and Pancreatic Cancer My Personal “Baptism by Fire”…
•
Dr. MacMahon (Harvard) study – New Engl J Med, 1981
•
Intense media coverage and months of lost coffee sales
•
His methodology & results were severely criticized by
university and industry scientists
•
MacMahon eventually retracted his conclusions almost
completely in 1986, but only in a brief letter in the NEJM
•
This study’s limitations have become famous teaching points
in human dietary epidemiology coursework.
12
16. As we entered the 21st Century…
The preponderance of medical and scientific
evidence clearly supported the conclusion that
moderate coffee consumption (3 - 4 cups per day),
as part of a varied, balanced diet, was safe and
was not associated with any adverse human health
consequences.
15
17. Caffeine’s Beneficial Physiological Effects
•
Mild central nervous system (CNS) stimulant
•
Improves cognitive performance and mental processing; increases
wakefulness; improves work performance and enhances mood
•
Increases capacity for physical work & exercise; improves
muscular performance and endurance sports
•
Relaxes smooth muscle, especially bronchial (opens airways), and
increases blood flow in heart and kidneys
•
Produces a slightly higher metabolic rate (some evidence of an
ergogenic “fat burning” effect).
17
18. Cardiovascular Disease
•
Endpoints: heart attack, hypertension (with stress), blood
cholesterol from boiled coffee, cardiac arrhythmias
•
Andersen et al., 2006 – Iowa Women’s Health Study,
decreased risk of cardiovascular death
•
Lopez-Garcia et al., 2006, 2008 (Harvard) – big cohort study in
men & women, no increased risk seen, even modest benefit for
all-cause and cardiovascular disease
•
Freedman et al., 2012 (NIH-AARP) – cohort study of over
400,000 men & women showed coffee consumption reduced
total mortality and cause-specific mortality.
18
19. Caffeine and Reproductive Effects
•
Began with birth defects in rats force-fed very high-doses
(FDA, 1978)
•
Then human studies followed: delayed conception;
premature birth; low birth weight babies; fetal death;
spontaneous abortion (miscarriage), congenital defects
•
But now there are more than 25 Published Reviews:
•
Peck, Leviton, Cowan (Food & Chemical Toxicology,
October 2010):
“The weight of evidence does not support a positive
relationship between caffeine consumption and
adverse reproductive or perinatal outcomes.”
19
20. Caffeine and Osteoporosis
•
Excess calcium loss & bone loss in post-menopausal
women causes millions of bone fractures (mostly hip)
•
Earlier acute, 24-hour human studies on non-caffeine
consuming subjects were originally misinterpreted
•
Many longer-term, human clinical studies have shown
little excess calcium loss or bone loss and no increased
risk of osteoporosis.
20
22. Caffeine and “Addiction”
•
Dependence, tolerance and withdrawal headache were cited in
many published studies (mostly among psychiatric patients)
•
Headlines since the late 1980’s:
•
•
•
“Caffeine Addiction More Than Just Java Jive -- Caffeine
Junkies”
“Study Finds Caffeine Has Qualities of Addictive Drug”
Current view is very reassuring:
•
Caffeine is not classified as an addictive drug (APA, DSM-5
psychiatric “bible” May 2013)
•
Addiction over-warnings trivialize dangers of real drugs of
abuse.
22
23. Coffee and Cancer Risk
•
Coffee contains dozens of animal carcinogens, many
produced by the “Maillard Browning Reaction” in the
presence of heat, including acrylamide
•
Over 500 human epidemiology studies have been
published since the 1970’s on many human organs
•
But, after 3 decades of human research, most health
authorities across the globe now agree that coffee
drinking is NOT a cancer risk!
23
24. “FOR MOST CANCER SITES, THERE IS A SIGNIFICANT AMOUNT OF
EVIDENCE SHOWING NO DETRIMENTAL EFFECT OF CONSUMPTION
OF UP TO 6 CUPS OF COFFEE/DAY IN RELATION TO CANCER
OCCURRENCE. IN FACT, SOME OF THE EVIDENCE…SUGGESTS
THAT COFFEE MIGHT PREVENT SOME CANCERS.”
[REVIEW BASED ON OVER 500 PUBLICATIONS]
24
25. Conclusions on the “Bad” Health Effects
•
Long established history of safe global coffee
consumption
•
But more animal, clinical & epidemiologic studies and
continued media attention are sure to come
•
More recent studies and re-examinations of older disease
issues have been quite reassuring
•
Consumers can be assured that their health will not be
adversely affected by the enjoyment of coffee and
caffeine as currently consumed.
25
27. “Risk Reductions” with Coffee Consumption
•
Some cancers (already reviewed)
•
Type 2 diabetes
•
Chronic liver disease
•
Parkinson’s Disease
•
Alzheimer’s Disease
27
28. Coffee and Type 2 Diabetes
•
Diabetes “epidemic” in Western societies with links to
obesity and premature death
•
Human epidemiological studies have all shown a
substantial reduction in risk with coffee consumption
•
Research is underway on promising coffee constituents,
and longer term human clinical trials are needed
•
Identification of coffee constituents with beneficial effects
on glucose metabolism may lead to the selection of coffees
with more positive health effects.
28
29. Liver Cancer and Liver Cirrhosis
•
Liver cancer is 5th most common cancer in the world,
and liver cirrhosis is a major risk factor for it
•
Coffee inhibits liver enzymes and produces a liverprotective effect that seems to reduce the risk of both
cirrhosis and liver cancer by as much as 45%
•
This is coffee’s strongest cancer-protective effect
•
Physiological studies are also providing strong
biological support.
29
30. Coffee Consumption and Reduced Risk of
Parkinson’s Disease (PD)
•
9 human studies found regular coffee consumers were
50-80% less likely to develop PD
•
In 2007, two large cohort studies also showed a graded
decrease in risk with more cups consumed
•
Further studies on caffeine’s neuroprotective effects
are required to demonstrate cause-effect conclusion.
30
31. Coffee and Reduced Risk of Alzheimer’s
Disease (AD)
•
Several human cohort studies have shown that coffee
consumption is associated with a reduced risk of AD
•
Caffeine has shown neuroprotective effects after chronic
administration in animals, possibly via changes in
neurotransmitter and receptor systems
•
Dr. Gary Arendash’s studies (U. of South Florida) in
animals and humans continue to support this good news
•
Wouldn’t we all love to avoid this disease?
31
32. Antioxidants (AOX) in Foods (Wine, Tea, Chocolate)
Extensive media coverage of AOX health benefits in all these
other foods and beverages, but coffee seems to get
mentioned so much less
The media know that the positive health effects are mainly
due to their polyphenol AOX content
However…Coffee is now known to be a much better source
of AOX than all of the others combined!
Not just coffee’s naturally occurring polyphenols (the
chlorogenic acids)
The brown melanoidin polymers are heat-produced AOX
from the Maillard Browning Reaction.
32
33. Coffee provides 64% of per capita AOXs from beverages
C
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a
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mg AOX/day
BEVERAGE - PER CAPITA AOX’S
800
700
600
500
400
300
200
100
0
33
34. So with all this good news, why
are we still concerned?
~
Caffeine Issues [Congress / FDA]
Animal Carcinogens in Coffee
34
41. Acrylamide Snapshot
Known for decades as an occupational neurotoxin
in humans; genotoxic / mutagenic in cell cultures
Known rat carcinogen, classified as a “probable
human carcinogen” in the 1990’s
Discovered unexpectedly by the Swedes in 2002 in
hundreds of heat-processed food products
[including coffee] due to the Maillard Browning
Reaction between sugars and amino acids.
40
48. Acrylamide Battleground under California Prop 65
Listed in 1990 as a carcinogen with a very low “Safe Harbor” intake
level = 0.2 micrograms/day; must stay below this level to avoid
cancer warnings
French fries: Attorney General sued and settled a case (2008) against
frozen fries/tater tots demanding a 50% reduction in levels; fast-food
restaurant fries have had cancer warnings posted for years
Potato chips: AG settled a case (2008) against chip manufacturers;
agreement to cut levels to 275 ppb by end of 2011 (20 - 85%
reductions) to avoid warnings; no warnings are currently being given
Cereals: Private “bounty hunter” lawyers sued cereal manufacturers
in 2009; case is still pending.
48
49. Coffee/Acrylamide Battles under Prop 65
Private “bounty hunter” (CERT, R. Metzger) sued California
coffee shops in April 2010 for failure to provide cancer
warnings (“brewed coffee” suit); in April 2011, the shops
began posting 10 x 10 inch cancer warning placards
covering coffee, baked goods and other browned products
CERT filed a related suit in May 2011 against coffee
roasters, distributors and retailers, over 120 companies are
now sued (“roasted coffee” suit)
Roasters are fighting hard to avoid cancer warning labels
on packaged products; levels average only about 10 ppb in
brewed coffee.
49
51. Using a Benefit-Risk Approach
for Coffee…
The “Holistic” Approach
~
“Coffee - Cancer Paradox”
51
52. Benefit-Risk Evaluation to Assess the Safety of
Foods Containing Heat-produced Carcinogens
Doing it the WRONG WAY for decades, by evaluating the risk
of individual chemicals in a food one by one (like Prop 65
does!)
I believe the RIGHT WAY is to evaluate the safety of the
whole food by comparing its risks vs. benefits
Use the “Holistic Approach”
“Benefit-Risk” evaluations have recently been published –
U.S. FDA’s 2009 “Draft Risk and Benefit Assessment of
Fish” (Methyl mercury risks vs. Omega-3 fatty acid
benefits)
52
53. “One by One” vs. the “Holistic” Approach
•
Foods and beverages contain huge numbers of
different chemical components that can have directly
opposite health effects
•
Assessing these chemicals “one by one” is highly
likely to be misleading and overly conservative,
especially for animal carcinogens produced in complex
heated foods (no better example than coffee!)
•
I believe the correct way forward for complex heated
foods and beverages requires the “Holistic” RiskBenefit approach, as opposed to the current “one by
one” chemical assessments.
53
54. Use the Holistic “Risk-Benefit” Approach
•
The beneficial health effects of certain whole foods may
outweigh the effects of trace levels of animal carcinogens and
other toxicants – COFFEE is one of these foods!
•
We must press global health and regulatory authorities to:
• Use improved toxicology & risk assessment methods on
individual chemicals tested at high doses in animals
• Do more research on qualitative and quantitative
assessment of the benefits of whole foods
• Consider the health benefits of protective compounds
naturally occurring and produced by heating (coffee’s
antioxidants)
• Assess the safety and benefits of the whole food, not just
individual food carcinogens & toxicants one by one.
54
55. The “Coffee / Cancer Paradox”
Coffee contains about 2,000 identified compounds (hundreds are
flavors and aromas), including trace levels of many animal
carcinogens
But global health and regulatory authorities now agree that coffee
drinking is NOT causing any increased risk of human cancer
In fact, human studies show significant risk reductions for numerous
cancers in spite of the presence of many animal carcinogens
How can this be?
Naturally occurring antioxidants (chlorogenic acids)
Heat-formed antioxidants (the brown melanoidin polymers)
Chemicals that induce detoxification enzymes
So, here is the Paradox – Coffee is loaded with animal
carcinogens but most likely reduces human cancer risk!
55