"Unmet need" generally indicates that a particular disease cannot be adequately treated, or perhaps treated at all. In this presentation, Koonal Shah notes the definitions and the approaches to measuring "need" that have appeared in the literature. A recent exploratory empirical study also is reviewed. This research focused on the extent to which member of the general public believe that "unmet need" should be ranked high in priority in decisions that allocate health care resources.
Describes in detail definition, purpose, participants and goal of good clinical practices (GCP). Gives history of GCP staring form Nuremberg code in 1948 to implementation of GCP guidance via WHO handbook in 2005. Also describes Nuremberg's code, declaration of Helsinki and Thirteen principles of GCP.
Real-World Evidence: The Future of Data Generation and UsageApril Bright
As data is captured through electronic health records, registries and unique device identifiers, the generation of evidence based on this data is expected to play a crucial role in informing orthopedic manufacturers’ decisions before and after regulatory approval. While regulators, payors, hospitals and manufacturers support this shift, they acknowledge that gaps remain in its optimal execution. Priority considerations include how to generate evidence to expedite regulatory market decisions, device indication expansion, postmarket studies, postmarket surveillance and reimbursement decisions. The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), is leading the conversation with various stakeholders, including FDA and orthopedic device companies to support the sustainable generation of Real-World Evidence (RWE) using Real-World Data (RWD).
The Presentation will take the reader through various ethical issues in biomedical research. It covers topics like The Nuremberg Code, Declaration of Helsinki, Declaration of Geneva, selected code and regulations that guide research with human subjects, etc.
Describes in detail definition, purpose, participants and goal of good clinical practices (GCP). Gives history of GCP staring form Nuremberg code in 1948 to implementation of GCP guidance via WHO handbook in 2005. Also describes Nuremberg's code, declaration of Helsinki and Thirteen principles of GCP.
Real-World Evidence: The Future of Data Generation and UsageApril Bright
As data is captured through electronic health records, registries and unique device identifiers, the generation of evidence based on this data is expected to play a crucial role in informing orthopedic manufacturers’ decisions before and after regulatory approval. While regulators, payors, hospitals and manufacturers support this shift, they acknowledge that gaps remain in its optimal execution. Priority considerations include how to generate evidence to expedite regulatory market decisions, device indication expansion, postmarket studies, postmarket surveillance and reimbursement decisions. The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), is leading the conversation with various stakeholders, including FDA and orthopedic device companies to support the sustainable generation of Real-World Evidence (RWE) using Real-World Data (RWD).
The Presentation will take the reader through various ethical issues in biomedical research. It covers topics like The Nuremberg Code, Declaration of Helsinki, Declaration of Geneva, selected code and regulations that guide research with human subjects, etc.
inform consent form before participate in clinical trials.for purpose of understanding the nature of research,risk,benefits,and decision about participation
In this PPt contain the E6 R1 and E6 R2 information , and the GCP training material for the Good prectice. and end of the ppt there is a ink which is use for your online training and generate certificate.
Feasibility Solutions to Clinical Trial Nightmaresjbarag
Slow patient recruitment and poor retention cause recurrent nightmares and perpetual problems often resulting in missing recruitment milestones. The cost of these delays represents hundreds of thousands of dollars for drug and device developers. By recognizing this issue, early detailed feasibility can provide planning and contingency solutions that are focused on reducing the impact of delayed recruitment. Furthermore understanding what motivates investigators and patients to actively participate in clinical studies and how patient recruitment strategies and materials can support all stakeholders to complete studies on time are critical aspects of clinical study delivery planning.
During this presentation, an experienced Premier Research feasibility and patient recruitment specialist, reviewed feasibility approaches to address protocol evaluation as well as addressed influences on country selection, site distribution and patient recruitment strategies to provide for more effective clinical trial planning and conduct.
For more information, go to http://www.premier-research.com.
Regulation Governing Clinical Trials In India,USA and Europe. KapilKumar198
This presentation contain detailed information about the "Regulation Governing Clinical Trials In India,USA and Europe".And about the clinical trails and medical devices regulations in India.
inform consent form before participate in clinical trials.for purpose of understanding the nature of research,risk,benefits,and decision about participation
In this PPt contain the E6 R1 and E6 R2 information , and the GCP training material for the Good prectice. and end of the ppt there is a ink which is use for your online training and generate certificate.
Feasibility Solutions to Clinical Trial Nightmaresjbarag
Slow patient recruitment and poor retention cause recurrent nightmares and perpetual problems often resulting in missing recruitment milestones. The cost of these delays represents hundreds of thousands of dollars for drug and device developers. By recognizing this issue, early detailed feasibility can provide planning and contingency solutions that are focused on reducing the impact of delayed recruitment. Furthermore understanding what motivates investigators and patients to actively participate in clinical studies and how patient recruitment strategies and materials can support all stakeholders to complete studies on time are critical aspects of clinical study delivery planning.
During this presentation, an experienced Premier Research feasibility and patient recruitment specialist, reviewed feasibility approaches to address protocol evaluation as well as addressed influences on country selection, site distribution and patient recruitment strategies to provide for more effective clinical trial planning and conduct.
For more information, go to http://www.premier-research.com.
Regulation Governing Clinical Trials In India,USA and Europe. KapilKumar198
This presentation contain detailed information about the "Regulation Governing Clinical Trials In India,USA and Europe".And about the clinical trails and medical devices regulations in India.
Ideation in Medical Device Development: Finding Clinical NeedsCIMIT
This presentation focuses on:
Decreasing failure by finding and developing a compelling need.
Understanding needs - finding and screening.
Selecting meaningful projects for entrepreneurial effort.
Sharing examples of needs and need statements.
Beginning a paradigm shift from technology push to need pull.
Dr. Henry Mosley of the Bloomberg School of Public Health at Johns Hopkins University discusses the global unmet need for contraception, the reasons behind the unmet need, and ways the problem can be addressed.
[Slides and the accompanying audio posted at http://www.portigal.com/blog/designing-for-unmet-needs-my-presentation-from-warm-gun]
Don’t be surprised if Steve Portigal, author of Interviewing Users, invites himself to your family breakfast or follows hotel maintenance staff to the boiler room. For more than 15 years, he’s led hundreds of interviews that help clients understand customers and turn insights into design opportunities.
Steve knows that our success depends on letting the unmet needs of our audience shape our designs. Okay—but how do we hit a target we can’t see? How do we design for people who aren’t us? How do we solve for the complexity of those people?
Dig into the details, ditch the guesswork, and join Steve to engage deliberately with the people we’re designing for. Look at ways to acknowledge the complexity of your users. Offer solutions rooted in the connections you make with people. Get unstuck and discover opportunities for design that adds value.
International Journal of Drug Regulatory Affairs; 2014, 2(1), 1- 11
Abstract:
Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This article focuses on drug approval process in different countries like USA, Europe and India.
The ASSA ABLOY Group released its interim report January-June 2013 on Friday 19 July 2013 at 08.00 am (CET). The presentation from the combined investors’ and analyst meeting and web conference is available as an on-demand webcast. Welcome to visit our Investor pages on http://www.assaabloy.com/investors/.
Please share this slideshow with anyone who may be interested!
Watch all our webinars: https://www.youtube.com/playlist?list=PL4dDQscmFYu_ezxuxnAE61hx4JlqAKXpR
In this webinar:
● Discussion of the CADTH Symposium
● Recommendations for HTA improvements in Canada
● Audience Q&A
View the video: https://youtu.be/AJCOemf2r6Y
Follow our social media accounts:
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In this presentation, Bill Dempster and Johanne Chambers of 3Sixty Public Affairs walk through the different steps in bringing a new medicine through the regulatory review process, health technology assessment and funding, highlighting where patients can make a difference, and how their role is rapidly expanding.
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.
Investing in specialised services - the prioritisation framework, pop up uni,...NHS England
Expo is the most significant annual health and social care event in the calendar, uniting more NHS and care leaders, commissioners, clinicians, voluntary sector partners, innovators and media than any other health and care event.
Expo 15 returned to Manchester and was hosted once again by NHS England. Around 5000 people a day from health and care, the voluntary sector, local government, and industry joined together at Manchester Central Convention Centre for two packed days of speakers, workshops, exhibitions and professional development.
This year, Expo was more relevant and engaging than ever before, happening within the first 100 days of the new Government, and almost 12 months after the publication of the NHS Five Year Forward View. It was also a great opportunity to check on and learn from the progress of Greater Manchester as the area prepares to take over a £6 billion devolved health and social care budget, pledging to integrate hospital, community, primary and social care and vastly improve health and well-being.
More information is available online: www.expo.nhs.uk
This research explores the feasibility of introducing an Outcome-Based Payment approach for new cancer drugs in England. A literature review explored the current funding landscape in England, the available evidence on existing OBP schemes internationally, and
which outcomes cancer patients value most. Two focus groups and an online survey with patients and carers, as well as interviews with NHS and government stakeholders, healthcare
professionals, and pharmaceutical industry representatives, provided additional evidence on the feasibility and suitability of OBP schemes
On 31 October 2019, Adrian Towse and Chris Henshall from the Office of Health Economics (OHE) presented at the G20 meeting on antimicrobial drugs R&D in Paris organised by the Wellcome Trust. The topic of their presentation was HTA and payment mechanisms for new drugs to tackle antimicrobial resistance.
This presentation looks at ways in which governments can set prices, including “cost plus”, value, and the external referencing of prices elsewhere. It looks at the role that competition can play in keeping down prices. In that context it briefly discusses pricing proposals being considered in Malaysia. It makes the case for using HTA to inform pricing decisions.
Adrian Towse
% GDP spending in UK, G5 countries and OECD upper middle income countries. W...Office of Health Economics
This presentation looks at rates of GDP spend on health care, distinguishing between categories of country (i.e. levels of GDP pre capita). It looks at the relationship between rates of spending and moves to universal health coverage, and explores alternative ways of increasing expenditure and making decisions about which services to provide with the money available.
The role of real world data and evidence in building a sustainable & efficien...Office of Health Economics
This presentation defines RWD and RWE in the context of digital health, and looks at potential uses for RWD and RWE. It briefly sets out the current landscape in Malaysia and looks at the challenges in using RWE. In particular, the issues of access, governance and ensuring good quality are considered.
The aim of this educational symposium was to discuss why we should seek value across the health care system and how we can apply existing research methods to measure the value of services. While considerable political attention in developed countries continues to be focused on drug spending, there is also growing awareness of the significant contribution of non-drug components of health care (e.g., hospital services and inefficient care delivery) to overall spending growth and patient affordability. At the same time, there is growing interest in making greater use of value assessment and value-based payment to control spending and better align it with care quality. In order to promote greater value, and to do so in ways that respond to the needs of payers and patients, it is essential to assess value across both drug- and non-drug interventions and health care services. This panel will offer expert viewpoints to identify and discuss gaps in value information, rationale and approaches to track and reduce system-wide low value care, and research methods for how to measure health care services.
Role Substitution, Skill Mix, and Provider Efficiency and Effectiveness : Les...Office of Health Economics
Graham participated in an organised session on Monday July 15th 2019. In the session he presented his paper with his co-author Ioannis Laliotis from the London School of Economics. The paper revisits the relationship between workforce and maternity outcomes in the English NHS in an attempt to contribute knowledge to an important policy question for which there has been a paucity of research.
Understanding what aspects of health and quality of life are important to peopleOffice of Health Economics
Poster presentation from the EuroQol Plenary Meeting 2019, Brussels, Belgium. By Koonal Shah, Brendan Mulhern, Patricia Cubi-Molla, Bas Janssen, and David Mott.
Koonal presented as part of an organised session on ‘moving beyond conventional economic approaches in palliative and end of life care’. He summarised the empirical evidence on the extent of pubic support for an end of life premium, before discussing some novel approaches that have been used in recent studies. His presentation was discussed by Helen Mason of Glasgow Caledonian University.
Author(s) and affiliation(s): Koonal Shah, Office of Health Economics
Event: iHEA Congress
Date: 17/07/2019
Location: Basel, Switzerland
Assessing the Life-Cycle Value Added of Second Generation Antipsychotics in S...Office of Health Economics
This research presented in a poster at HTAi 2019, Cologne (Germany) by a team of OHE and IHE researchers, estimates the value added by second generation antipsychotics over their life-cycle in the UK and Sweden. It concludes that considering the entire life-cycle, the value added by SGAs to the system is higher than the expected value estimated at launch. P&R decisions should consider how to measure, capture and take into account the value added by medicines over the long-run.
Author(s) and affiliation(s): Mikel Berdud (Office of Health Economics, London), Niklas Wallin-Bernhardsson (Institute for Health Economics, Stockholm), Bernarda Zamora (Office of Health Economics, London), Peter Lindgren (Institute for Health Economics, Stockholm), Adrian Towse (Office of Health Economics, London)
Event: HTAi 2019 Annual Meeting
Date: 18/06/2019
Location: Cologne, Germany
There is growing recognition that HTA and contracting systems for antimicrobials need to be adapted to help fight the threat of antimicrobial resistance (AMR), but there is little agreement on how. This poster reports findings from a literature review, expert interviews and face-to-face discussions at a Forum on the current HTA and payment systems for antibiotics across Europe and a number of recommendations for adapting these systems to respond to the challenges of AMR.
Author(s) and affiliation(s): Margherita Neri (OHE) Grace Hampson (OHE) Christopher Henshall (OHE visiting fellow, independent consultant) Adrian Towse (OHE)
Event: HTAi annual conference 2019
Date: 18/06/2019
Location: Cologne, Germany
Assessing the Life-cycle Value Added of Second-Generation Antipsychotics in S...Office of Health Economics
This study aims to guide access decisions and drive the discussion on access and price, through recognition of the dynamic nature of value added by pharmaceutical innovation over the long-run. The analysis of the life-cycle value of risperidone estimates the value generated in the UK and Sweden. Results show that health systems were able to appropriate most of the life-cycle value generated, and this is larger than estimated at launch.
Author(s) and affiliation(s): Mikel Berdud(1), Niklas Wallin-Bernhardsson(2), Bernarda Zamora(1), Peter Lindgren(2), and Adrian Towse(1) (1) Office of Health Economics (2) The Swedish Institute for. Health Economics
Event: XXXIX JORNADAS DE ECONOMÍA DE LA SALUD
Date: 12/06/2019
Location: Albacete, Spain
Prescribed Specialised Services (PSS) Commissioning for Quality and Innovation (CQUIN) schemes were launched in 2013 in England with the aim of improving the quality of specialised care and achieving value for money. During this presentation, Marina Rodes Sanchez described the key features of the schemes and discussed its strengths and weaknesses based on international pay-for-performance literature.
Author(s) and affiliation(s): Yan Feng, Queen Mary University of London; Søren Rud Kristensen, Imperial College London; Paula Lorgelly, King’s College London; Rachel Meacock, University of Manchester; Marina Rodes Sanchez, Office of Health Economics; Luigi Siciliani, University of York; Matt Sutton, University of Manchester
Event: XXXIX Spanish Health Economics Association Conference
Date: 12/06/2019
Location: Albacete, Spain
In this session, Meng Li sets out estimates of real option value for drugs arguing that option value matters and can be calculated. Adrian Towse sets out likely payer concerns about incorporating real option value into decision making. Meng Li responds to these concerns. Jens Grueger sets out how industry considers investment opportunities, arguing that if patients (and society) have preferences these need to be reflected in P&R decisions.
Author(s) and affiliation(s): Meng Li, Postdoctoral Research Fellow, Leonard D Schaeffer Center, University of Southern California, Los Angeles, CA, USA. Adrian Towse, Emeritus Director, Office of Health Economics, London, UK Jens Grueger, formerly Head of Global Access, Senior Vice President at F. Hoffmann-La Roche
Event: ISPOR 2019
Location: New Orleans, USA
Date: 21/05/2019
MCDA OR WEIGHTED CEA BASED ON THE QALY? WHICH IS THE FUTURE FOR HTA DECISION ...Office of Health Economics
In this ISPOR session Chuck Phelps and Adrian Towse debated the case for and against using MCDA to support HTA decision making, as compared to weighting or augmenting a QALY based ICER approach. Chuck Phelps argued for use of MCDA, Adrian Towse for weighting the QALY. Nancy Devlin set the scene and moderated.
Author(s) and affiliation(s): Nancy Devlin, Director, Centre for Health Policy, University of Melbourne, Australia Adrian Towse, Emeritus Director, Office of Health Economics, London, UK Chuck Phelps, University of Rochester, Rochester, NY USA
Event: ISPOR 2019
Location: New Orleans, USA
Date: 21/05/2019
The issue of open-source models in the cost-effectiveness and disease-level (collaborative) models has been brewing for many years. There has been a marked growth in open science, and funding bodies and publishers increasingly require that research data be made available. As mentioned in our previous Issue Panel, “cost-effectiveness models synthesise a wide range of evidence to facilitate extrapolation over time and from intermediate to final decision endpoints. These models are often statistically sophisticated and require assumptions that are not directly testable. This can lead to decision-makers “discounting” the results of cost-effectiveness analyses, particularly if the developer is seen as partial.” Open-source models, then, would encourage greater transparency in pharmacoeconomic modeling and the reuse and updating of the best/most useful models; they are essential if cost-effectiveness analyses are to be widely accepted to reduce bias, increase transparency, improve model access, and allow for faster access to critical knowledge. The ISPOR-SMDM guidelines and the EUnetHTA joint action projects, are supportive of these views on collaboration, transparency, confidentiality, processes and consistency offered by the availability of open-source models to improve decision-making around health care and reimbursement. With openness and sharing, however, come issues of copyright and access and a need to define how model sharing can be achieved in a fair and equitable manner. There is, therefore, a need to develop an ongoing dialog on openness, especially where the research may be considered precompetitive and not worthy of IP investment. The pros and cons of open source models and the proposed mission of the Open Source Model SIG to curate an ongoing dialog regarding issues around creating, disseminating, sharing, evaluating, and updating open source cost-effectiveness and comparative effectiveness models will be debated amongst SIG members.
Author(s) and affiliation(s): Nancy Risebrough, Senior Principal, ICON plc, Toronto, Canada Jeroen P Jansen; Innovation & Value Initiative; Precision Medicine Group; and Stanford University Lotte Steuten, Vice President & Head of Consulting, Office of Health Economics, UK Renée JG Arnold, PharmD, RPh, ICON plc, New York, NY and Icahn School of Medicine at Mount Sinai, New York, NY, USA
Event: ISPOR 2019 Annual Meeting
Date: 20/05/2019
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.
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
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
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
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.
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
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
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
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.
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
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 Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...
"Unmet need" in health care and economic value
1. "Unmet Need" as a Potential
Source of Economic Value in
Value-based Pricing Schemes
Koonal Shah
PharmAccess Leaders Forum
Berlin • 16-18 October 2013
2. Background
•
Stated objective of the UK government’s
proposed "value-based pricing" scheme:
“…to include a wide assessment, alongside
clinical effectiveness, of the range of factors
through which medicines deliver benefits for
patients and society...”
• The consultation document suggests that higher
prices will be granted to medicines that tackle
diseases that are severe or are associated with
unmet need
PHARMACCESS LEADERS FORUM
16/10/2013 2
3. Background
•
Lack of clarity about:
•
•
•
How these components should be defined
What evidence is needed to generate measures that
can be applied in a "value-based pricing" scheme
This presentation focuses on the definition of
unmet need and the evidence supporting the
use of unmet need as a source of value
PHARMACCESS LEADERS FORUM
16/10/2013 3
4. Defining "unmet need"
“Unmet need could reflect the degree to which there are
existing treatments. A condition for which there is no
effective treatment, and where there is, therefore,
significant unmet need, could be characterised by a high
QALY loss, and deemed to exhibit a high ‘Burden of Illness’.
Conversely, conditions that were already well served with
effective treatments would be scored at a lower level of this
measure – even if the untreated condition was itself severe
and life-threatening.”
VBP consultation document para 4.18
PHARMACCESS LEADERS FORUM
16/10/2013 4
5. Defining unmet need
•
“…‘unmet medical needs’ means a condition
for which there exists no satisfactory method
of diagnosis, prevention or treatment
authorised in the Community or, even if such a
method exists, in relation to which the
medicinal product concerned will be of major
therapeutic advantage to those affected.”
Commission Regulation (EC) No. 507/2006
(EC Regulation on the conditional marketing authorisation for medicinal
products for human use)
PHARMACCESS LEADERS FORUM
16/10/2013 5
6. Defining unmet need
•
Some definitions of unmet need are concerned
with whether the services are being received
rather than whether they exist – e.g. Carr and
Wolfe (1976)
•
Unmet need due to individual budget constraint
may arise for underserved individuals with low
socioeconomic status – e.g. Kataoka et al.
(2002)
•
Some researchers note that unmet need has
two dimensions: the per-patient level and the
number of patients with this level of need
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7. Unmet need in VBP schemes
Kanavos, P et al. (2009) The role of
.
funding and policies on innovation in
cancer drug development.
London: London School of Economics
and Political Science
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8. Understanding society’s
preferences
• UK VBP proposals focus on "what society
values"
• Whilst there is a growing body of evidence on
the extent to which society supports the use of
severity in health care priority setting, few
published empirical studies examine people’s
preferences regarding unmet need
• Tappenden et al. (2007) – preferences of NICE
appraisal committee members
• Green and Gerard (2009) – public preferences
• Linley and Hughes (2013) – public preferences
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9. Preference study
• Objective: to develop a greater understanding of
the extent of societal support for prioritising of
health care resources according to disease
severity and unmet need, using preference data
elicited from members of the UK general public
• By no means a definitive assessment of society’s
preferences
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10. Methods
• Respondents from the general public
• Face-to-face interviews conducted in respondents’ homes
• Survey on health care priority setting
• Seven choice tasks
•
Involved choosing between treatments for conditions which
differed in terms of unmet need and/or severity and/or
health gain from treatment
• General attitudinal questions about NHS priorities
• One budget allocation question
•
Repeat of earlier choice task but with more response options
• Open-ended comment regarding unmet need task
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12. Questionnaire
Patient group A
Patient group B
Testing
what?
Life
expectancy
Life
extension
Other
treatments?
Life
expectancy
Life
extension
Other
treatments?
Q1
5
2
Yes
5
1
Yes
HG
Q2
5
1
Yes
1
1
Yes
SV
Q3
5
2
Yes
1
1
Yes
HG x SV
Q4
5
1
No
5
1
Yes
UN
Q5
5
1
No
5
1
Yes
UN+
Q6
5
1
No
1
1
Yes
UN x SV
Q7
5
1
No
5
2
Yes
UN x HG
-
-
-
-
-
-
-
-
Q10
5
1
No
5
1
Yes
UN
(but difficult
to take)
HG = health gain; SV = severity; UN = unmet need; UN+ = ‘partial’ unmet need
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13. Methods of analysis
• Distribution of responses to each question
• Comparing respondents’ responses from one
question to another
• Variety of face validity tests
• Independent selection of open-ended comments
that are of relevance to unmet need
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14. Results – sample
60 respondents (30 in London; 30 in Kent)
Characteristic
40
48
60
52
18-34
26
29
51
50
65+
Social grade
Male
35-64
Age
General
pop.
Female
Gender
%
21
21
A
0
3
B
8
20
C1
48
28
C2
22
21
DE
22
28
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15. Results – aggregate response data
Option A
Q1
Option B
Strongly
A
Slightly A
No pref
Slightly B
Strongly
B
Larger gain
Smaller gain
58%
30%
7%
2%
3%
88%
Q2
Moderately ill
Severely ill
38%
7%
15%
53%
Q3
Q4
Q5
Q6
Q7
Larger gain +
moderately ill
Smaller gain
+ severely ill
33%
Unmet need
No unmet
need
20%
Partial unmet
need
10%
Unmet need +
moderately ill
No unmet
need +
severely ill
20%
Unmet need +
smaller gain
No unmet
need + larger
gain
10%
Unmet need
20%
10%
23%
57%
18%
40%
20%
20%
37%
15%
23%
42%
15%
43%
22%
22%
5%
48%
33%
15%
15%
17%
40%
15%
22%
5%
25%
20%
27%
17%
37%
18%
20%
25%
10%
5%
10%
43%
23%
30%
53%
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16. Results – aggregate response data
Q8
I think that the NHS should give priority to
treating patients for whom there are no
other treatments available
43%
I think that the NHS should give priority to
treating patients who will get the largest
health gain from treatment
57%
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17. Results – Q10
0% to A; 100% to B
10% to A; 90% to B
20% to A; 80% to B
30% to A; 70% to B
40% to A; 60% to B
50% to A; 50% to B
60% to A; 40% to B
70% to A; 30% to B
80% to A; 20% to B
90% to A; 10% to B
100% to A; 0% to B
0%
10%
20%
30%
40%
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50%
18. Results – Q4 vs. Q10
Q10 Q4
100% A
Strongly A
Slightly A
No pref.
Slightly B
1
Strongly B
Total
1
90% A
1
1
80% A
2
70% A
4
3
1
60% A
1
3
3
50 : 50
2
6
7
60% B
1
2
1
4
8
4
23
2
2
2
80% B
2
12
12
12
1
2
5
1
2
1
90% B
Total
9
1
1
70% B
100% B
2
1
7
14
10
60
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19. Results – focus on unmet need
• Five of the choice tasks examine unmet need preferences
•
Q4 – unmet need vs. no unmet need
•
Q5 – unmet need vs. partial unmet need
–
Existing treatments are difficult to take and cause disruption to patients’ lives
•
Q6 – unmet need + less severity vs. no unmet need vs. more severity
•
Q7 – unmet need + smaller gain vs. no unmet need + larger gain
•
Q10 – unmet need vs. no unmet need (budget allocation framing)
• Whilst distribution of responses differs from task to task, none
suggests that, on average, society supports giving higher priority
to treatments that address unmet need
• But Q8 (attitudinal/opinion question) tells a different story
•
(although there remains strong evidence of a relationship between Q7 and Q8; p=0.99)
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20. Face validity of the data
•
We conducted checks of consistency across questions
•
Interviewers also reported their assessments of
respondent understand and effort
•
Interviewer assessments predicted fairly well how likely
respondents were to give inconsistent answers (as judged by
us)
•
Excluding respondents who we suspect were not
answering "properly" makes little/no difference to results
•
Both respondents who understood/concentrated and those who did
not tended to go for a 50:50 split in Q10
•
Survey administered by trained, experienced interviewers
•
Questions no more complex than those used elsewhere in
the empirical ethics literature
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21. Comments left by respondents
• 18 of the 60 respondents left comments that we
considered to be relevant in terms of unmet need
• Examples:
•
“Strong preference that if no treatments are available for
condition A – then this should be prioritised.”
•
“Being a new breakthrough treatment I thought it worth giving
slightly more of the budget.”
•
“Condition B has an alternative to choose from there is still hope
for alternative B”
•
“There should be a higher focus on finding new treatments for
patients and then on looking at treatments to replace old ones.”
•
Both conditions patients die after 5 yrs. A no treatment 5 yrs. B
Treatment 5yrs. As far as I can see the overall scenario for both
A+B is the same.”
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22. Concluding remarks
• Unmet need typically described in terms of the
availability of alternative treatment options,
though other definitions exist
• (Sparse) literature suggests that at least some
members of the society consider unmet need to
be a valid health care priority setting criterion
• Estimating the strength of society’s preferences
is challenging
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