In clinical trials and other scientific studies, an interim analysis is an analysis of data that is conducted before data collection has been completed. If a treatment is particularly beneficial or harmful compared to the concurrent placebo group while the study is on-going, the investigators are ethically obliged to assess that difference using the data at hand and to make a deliberate consideration of terminating the study earlier than planned.
In interim analysis, whenever a new drug shows adverse effect on human being while testing the effectiveness of several drugs, we immediately stop the trial by taking into account the fact that maximum number of patients receive most effective treatment at the earliest stage. Interim analysis is also used to possibly reduce the expected number of patients and to shorten the follow-up time needed to make a conclusion. One wouldn't have to spend extra money if he/she already have enough evidence about the outcome. In this presentation, the total sample size is divided into four equal parts to perform the analysis and decision is made based on each individual step.
Application of Survival Data Analysis- Introduction and Discussion (存活数据分析及应用- 简介和讨论), will give an overview of survival data analysis, including parametric and non-parametric approaches and proportional hazard model, providing a real life example of survival data-based field return analysis. Several common issues in survival data analysis will also be discussed.
In clinical trials and other scientific studies, an interim analysis is an analysis of data that is conducted before data collection has been completed. If a treatment is particularly beneficial or harmful compared to the concurrent placebo group while the study is on-going, the investigators are ethically obliged to assess that difference using the data at hand and to make a deliberate consideration of terminating the study earlier than planned.
In interim analysis, whenever a new drug shows adverse effect on human being while testing the effectiveness of several drugs, we immediately stop the trial by taking into account the fact that maximum number of patients receive most effective treatment at the earliest stage. Interim analysis is also used to possibly reduce the expected number of patients and to shorten the follow-up time needed to make a conclusion. One wouldn't have to spend extra money if he/she already have enough evidence about the outcome. In this presentation, the total sample size is divided into four equal parts to perform the analysis and decision is made based on each individual step.
Application of Survival Data Analysis- Introduction and Discussion (存活数据分析及应用- 简介和讨论), will give an overview of survival data analysis, including parametric and non-parametric approaches and proportional hazard model, providing a real life example of survival data-based field return analysis. Several common issues in survival data analysis will also be discussed.
An Introductory Presentation to Clinical Research. A go through from this presentation will give you a brief and clear introduction about Clinical Research.
Regulation in clinical trial, Schedule Y and recent amendmentsDr. Siddhartha Dutta
Regulatory framework of India, Acts and Regulations for conduct of clinical trial in India, Schedule Y, approval of new chemical entity and recent amendments
Experimental design is a way to carefully plan experiments in advance so that results are both objective and valid. Ideally, an experimental design should:
• Describe how participants are allocated to experimental groups. A common method is completely randomized design, where participants are assigned to groups at random. A second method is randomized block design, where participants are divided into homogeneous blocks (for example, age groups) before being randomly assigned to groups.
• Minimize or eliminate confounding variables, which can offer alternative explanations for the experimental results.
• Allows making inferences about the relationship between independent variables and dependent variables.
• Reduce variability, to make it easier to find differences in treatment outcomes.
Types of Experimental Design
1. Between Subjects Design.
2. Completely Randomized Design.
3. Factorial Design.
4. Matched-Pairs Design.
5. Observational Study
• Longitudinal Research
• Cross Sectional Research
6. Pretest-Posttest Design.
7. Quasi-Experimental Design.
8. Randomized Block Design.
9. Randomized Controlled Trial
10. Within subjects Design.
the Pharmacovigilance Program of India (PvPI) was launched with a broad objective to safe guard the health of 1.27 billion people of India. Adverse drug Reactions (ADRs) are reported from all over the country to NCC-PvPI, which also work in collaboration with the global ADR monitoring centre (WHO-UMC), Sweden to contribute in the global ADRs data base. NCC-PvPI monitors the ADRs among Indian population and helps the regulatory authority of India (CDSCO) in taking decision for safe use of medicines.
(I) MEDICAL RESEARCH_ UNIT_III_RESEARCH METHODOLOGY & BIOSTATISTICS.pptxRAHUL PAL
Research Methodology and Biostatistics syllabus:
Medical Research: History, values in medical ethics, autonomy, beneficence, non-maleficence, double effect, conflicts between autonomy.
Medical research has a long and varied history. It has evolved from rudimentary practices to sophisticated, evidence-based methodologies. Some key milestones include the development of the scientific method, the use of randomized controlled trials, the discovery of antibiotics, and the mapping of the human genome. Ethical concerns have also played a significant role in shaping the history of medical research, especially in response to various ethical violations, such as the Tuskegee Syphilis Study and the Nuremberg Trials.
Resolving conflicts between these principles often requires careful consideration, ethical analysis, and, in some cases, consultation with ethics committees or boards. The specific course of action may vary based on the individual circumstances and ethical frameworks employed by healthcare professionals and researchers. Ethical guidelines and regulations also play a significant role in addressing and preventing these conflicts in medical research.
MedicReS Winter School 2017 Vienna - Importance of Selection of Outcomes - Ma...MedicReS
Importance of Selection of Outcomes and Covariates in Comparative Effectiveness of Cancer ...
International Conference Good Biostatistical and Publication Practice in Cancer Research with “Real Work Data”
February 13-14th, Vienna
Mariana Chavez Mac GregorMD, MSc.
Assistant Professor, Health Services Research Department
Breast Medical Oncology Department
An Introductory Presentation to Clinical Research. A go through from this presentation will give you a brief and clear introduction about Clinical Research.
Regulation in clinical trial, Schedule Y and recent amendmentsDr. Siddhartha Dutta
Regulatory framework of India, Acts and Regulations for conduct of clinical trial in India, Schedule Y, approval of new chemical entity and recent amendments
Experimental design is a way to carefully plan experiments in advance so that results are both objective and valid. Ideally, an experimental design should:
• Describe how participants are allocated to experimental groups. A common method is completely randomized design, where participants are assigned to groups at random. A second method is randomized block design, where participants are divided into homogeneous blocks (for example, age groups) before being randomly assigned to groups.
• Minimize or eliminate confounding variables, which can offer alternative explanations for the experimental results.
• Allows making inferences about the relationship between independent variables and dependent variables.
• Reduce variability, to make it easier to find differences in treatment outcomes.
Types of Experimental Design
1. Between Subjects Design.
2. Completely Randomized Design.
3. Factorial Design.
4. Matched-Pairs Design.
5. Observational Study
• Longitudinal Research
• Cross Sectional Research
6. Pretest-Posttest Design.
7. Quasi-Experimental Design.
8. Randomized Block Design.
9. Randomized Controlled Trial
10. Within subjects Design.
the Pharmacovigilance Program of India (PvPI) was launched with a broad objective to safe guard the health of 1.27 billion people of India. Adverse drug Reactions (ADRs) are reported from all over the country to NCC-PvPI, which also work in collaboration with the global ADR monitoring centre (WHO-UMC), Sweden to contribute in the global ADRs data base. NCC-PvPI monitors the ADRs among Indian population and helps the regulatory authority of India (CDSCO) in taking decision for safe use of medicines.
(I) MEDICAL RESEARCH_ UNIT_III_RESEARCH METHODOLOGY & BIOSTATISTICS.pptxRAHUL PAL
Research Methodology and Biostatistics syllabus:
Medical Research: History, values in medical ethics, autonomy, beneficence, non-maleficence, double effect, conflicts between autonomy.
Medical research has a long and varied history. It has evolved from rudimentary practices to sophisticated, evidence-based methodologies. Some key milestones include the development of the scientific method, the use of randomized controlled trials, the discovery of antibiotics, and the mapping of the human genome. Ethical concerns have also played a significant role in shaping the history of medical research, especially in response to various ethical violations, such as the Tuskegee Syphilis Study and the Nuremberg Trials.
Resolving conflicts between these principles often requires careful consideration, ethical analysis, and, in some cases, consultation with ethics committees or boards. The specific course of action may vary based on the individual circumstances and ethical frameworks employed by healthcare professionals and researchers. Ethical guidelines and regulations also play a significant role in addressing and preventing these conflicts in medical research.
MedicReS Winter School 2017 Vienna - Importance of Selection of Outcomes - Ma...MedicReS
Importance of Selection of Outcomes and Covariates in Comparative Effectiveness of Cancer ...
International Conference Good Biostatistical and Publication Practice in Cancer Research with “Real Work Data”
February 13-14th, Vienna
Mariana Chavez Mac GregorMD, MSc.
Assistant Professor, Health Services Research Department
Breast Medical Oncology Department
The C. Everett Koop National Health Award recognizes population health promotion and improvement programs. Each year, awards are presented by The Health Project’s leadership to winning organizations as part of the annual HERO Forum each fall. This Thursday Ron Goetzel joins us for an update on the C. Everett Koop National Health Award with information on criteria and how to apply.
The Role of Risk Stratification and Biomarkers in Prevention of CVDCTSI at UCSF
Presented by Mark Pletcher, MD, MPH, at UCSF's symposium "The Role of Risk Stratification and Biomarkers in Prevention of Cardiovascular Disease" in Jan 2012.
Elaboración de recomendaciones en GPC. Sistema GRADEGuíaSalud
Presentación realizada por Nicola Magrini, Director del Centro de evaluación de efectividad de cuidados en salud del Sistema Nacional de Salud de Italia, sobre el uso del Sistema GRADE para la elaboración de guías de práctica clínica. Presentación realizada en la Jornada Cienfífica de GuíaSalud 2011 "Avances en el desarrollo de Guías de Práctica Clínica".
Portal GuíaSalud http://www.guiasalud.es
Real-life examples of manuscript reviews Comparison and contrast of useful ...OARSI
Aileen Davis, PhD
Senior Scientist and Division Head,
Health Care and Outcomes Research,
Krembil Research Institute,
University Health Network and
Professor, University of Toronto
Real-life examples of manuscript reviews Comparison and contrast of useful ...OARSI
Aileen Davis, PhD
Senior Scientist and Division Head,
Health Care and Outcomes Research,
Krembil Research Institute,
University Health Network and
Professor, University of Toronto
How to write an effective review (and help editors and authors)OARSI
Rik Lories, MD PhDProfessor of Experimental Rheumatology
Director of the Laboratory of Tissue Homeostasis and Disease
KU Leuven, Skeletal Biology and Engineering Research Centre and University Hospitals Leuven, Division of Rheumatology
Joel A Block, MD
The Willard L Wood MD Professor, and
Director, Division of Rheumatology, Rush University Medical Center
Editor in Chief, Osteoarthritis and Cartilage
Real-life examples of manuscript reviews Comparison and contrast of useful ...OARSI
Senior Scientist and Division Head,
Health Care and Outcomes Research,Krembil Research Institute,
University Health Network and
Professor, University of Toronto
Professor of Radiology and Medicine
Vice Chair, Academic Affairs
Assistant Dean of Diversity
Director, Quantitative Imaging Center (QIC)
Boston University School of Medicine, Boston, MA
Nuts & Bolts of Systematic Reviews, Meta-analyses & Network Meta-analysesOARSI
Director, Applied Health Research Centre (AHRC)
Li Ka Shing Knowledge Institute, St. Michael’s Hospital
Professor, Department of Medicine & IHPME, University of Toronto
Tier 1 Canada Research Chair in Clinical Epidemiology of Chronic Diseases
Structural Targets for Prevention of Post Traumatic OAOARSI
David Hunter MBBS, PhD, FRACP
Florance and Cope Chair of Rheumatology, Professor of Medicine
University of Sydney and Royal North Shore Hospital
Chair, Institute of Bone and Joint Research
Chair, Musculoskeletal, Sydney Medical Program
Consultant Rheumatologist, North Sydney Orthopedic and Sports Medicine
Building a translational team for impacting public policyPre-Congress Worksh...OARSI
David Hunter MBBS, PhD, FRACP
Florance and Cope Chair of Rheumatology, Professor of Medicine
University of Sydney and Royal North Shore Hospital
Chair, Institute of Bone and Joint Research
Consultant Rheumatologist, North Sydney Orthopedic and Sports Medicine
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
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
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.
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
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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.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
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
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
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.
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- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
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Hemodialysis: Chapter 3, Dialysis Water Unit - Dr.Gawad
What are Patient Preferences, How Do You Measure Patient Preferences, and How Do I Use Them?
1. What Are Patient Preferences,
How Do You Measure Patient
Preferences, and
How Do I Use Them?
Deborah A Marshall, PhD
Professor and Arthur J.E. Child Chair in
Rheumatology Research
Cumming School of Medicine
OARSI, Toronto, May 3, 2019
2. 2
At the end of this session participants will be able to:
1. Differentiate between patient reported outcome and
experience measures (PROMs and PREMs) and patient
preferences
2. Identify and describe good research practices to develop,
design, and execute a patient preferences survey
3. Describe how patient preferences can be measured and
how to interpret the results from patient preferences
studies
4. Identify ways in which patient preferences can be applied in
clinical practice for patients with osteoarthritis
Learning Objectives
3. What are Patient Reported Outcome Measures
(PROMs) and Patient Reported Experience
Measures (PREMs)?
PROMs PREMs
Umbrella term that includes
outcome data reported directly by
the patient
Encompasses range of interactions that
patients have with health care system - care
from doctors, nurses, and staff in hospitals,
health care facilities
Includes global impressions,
functional status, well-being,
symptoms, health-related quality of
life, satisfaction
ACR core set of 3 PROMs: physical
function, pain, global assessment
of disease activity
Communication with doctors and nurses; Pain
management; Timeliness of assistance;
Explanation of medications administered;
Different from patient satisfaction (which
relates to meeting expectations)
Example:
Health Assessment Questionnaire
(HAQ)
Example: Hospital Consumer Assessment of
Healthcare Providers and Systems Survey
(HCAHPS)
- Van Tuyl et al. Rheum Dis Clin N Am 2016; Felson et al. Arth Rheum 1993; Felson et al. Arth Rheum 1995 ; Manery et al. N Engl J Med 2013
4. Beyond PROMS and PREMS –
Preferences Consider Choices and Trade-Offs
• Experimental survey methods that ask respondents
to express the relative desirability or acceptability of
features that differ amongst alternatives …which
reflects their underlying utility for that alternative
Attributes Treatment A Treatment B
Functional Improvement 20% improvement 40% improvement
Side Effects Mild Moderate
Mode of Administration Oral Injection
Which Treatment would you
choose? □ □
- Medical Device Innovation Consortium Framework for Patient-Centered Benefit-Risk Assessment, 2015
5. Arthritis is a ‘preference sensitive’ condition
Treatments are preference sensitive with a key issue of
compliance and adherence to therapy.
5
6. Patient Preference Methods
Medical Device Innovation Consortium Catalogue of Methods
Source: MDIC PCBR Framework Report Release Event, May 13, 2015.
Available at: http://mdic.org/pcbr-framework-report-release/
Group Method
Structured-
weighting
• Simple direct weighting
• Ranking exercises
• Swing weighting
• Point allocation
• Analytic hierarchy process
• Outranking methods
Health-state
utility
• Time tradeoff
• Standard gamble
Stated-
preference
• Direct-assessment questions
• Threshold technique
• Discrete-choice experiments
• Best-worst scaling exercises
Revealed-
preference
• Patient-preference trials
• Direct questions in clinical trials
7. Preference Methods
• For uni-dimensional decisions
(i.e., consider one attribute or outcome at a time)
– Standard Gamble
– Time tradeoff
– Contingent valuation
• For multi-dimensional decisions
(i.e., consider multiple attributes or outcomes
simultaneously)
– ConjointAnalysis
– Best-Worst Scaling (BWS)
– Discrete-Choice Experiments (DCE)*
– Analytic Hierarchy Process (AHP)
7
8. – Respondents choose amongst a set of alternatives
– Each alternative is a profile defined by attributes
– (e.g., efficacy, tolerability, mode of administration, cost, etc…)
– Each attribute can take on different levels
– For example, if efficacy attribute is defined as a response rate, then
levels could be
– 60 out of 100 (60%)
– 75 out of 100 (75%)
– 85 out of 100 (85%)
Direct Preference Elicitation with Discrete-
Choice Experiment (DCE)
9. – Profiles are combined into sets in each choice task
– Alternative choice formats can include
• two or more active alternatives (forced choice),
• opt-out or status quo (neither or none)
• Each respondents completes a series of choice tasks
• Each choice task has a different set of profiles determined by an
experimental design
• The key to a DCE is that one alternative is chosen in each
choice task
Direct Preference Elicitation with Discrete-
Choice Experiment (DCE)
10. Anatomy of a DCE Choice Task
Attributes
Prefer 1 Prefer 2
X Prefer 1 Prefer 2
X
Outcome Medicine 1 Medicine 2
Response Rate
90 out of 100
(90%)
50 out of 100
(50%)
Adverse Event Rate
10 out of 100
(10%)
1 out of 100
(1%)
Which medicine would you
prefer?
Prefer 1 Prefer 2
Attributes
Benefit
Risk
11. Anatomy of a DCE Choice Task
Attribute Levels
Prefer 1 Prefer 2
X Prefer 1 Prefer 2
X
Outcome Medicine 1 Medicine 2
Response Rate
90 out of 100
(90%)
50 out of 100
(50%)
Adverse Event Rate
10 out of 100
(10%)
1 out of 100
(1%)
Which medicine would you
prefer?
Prefer 1 Prefer 2
Attribute
Levels
12. Anatomy of a DCE Choice Task
Profile
Prefer 1 Prefer 2
X Prefer 1 Prefer 2
X
Outcome Medicine 1 Medicine 2
Response Rate
90 out of 100
(90%)
50 out of 100
(50%)
Adverse Event Rate
10 out of 100
(10%)
1 out of 100
(1%)
Which medicine would you
prefer?
Prefer 1 Prefer 2
Profile
Attributes
Benefit
Risk
13. Anatomy of a DCE Choice Task
Choice
Prefer 1 Prefer 2
X Prefer 1 Prefer 2
X
Outcome Medicine 1 Medicine 2
Response Rate
90 out of 100
(90%)
50 out of 100
(50%)
Adverse Event Rate
10 out of 100
(10%)
1 out of 100
(1%)
Which medicine would you
prefer?
Prefer 1 Prefer 2
X
Choice
14. Anatomy of a DCE Choice Task
Series of Choice Tasks
Outcome Medicine 1 Medicine 2
Response Rate
90 out of 100
(90%)
50 out of 100
(50%)
Adverse Event Rate
10 out of 100
(10%)
1 out of 100
(1%)
Which medicine would you
prefer?
Prefer 1 Prefer 2
X
Outcome Medicine 1 Medicine 2
Response Rate
90 out of 100
(90%)
50 out of 100
(50%)
Adverse Event Rate
10 out of 100
(10%)
1 out of 100
(1%)
Which medicine would you
prefer?
Prefer 1 Prefer 2
X
Outcome Medicine 1 Medicine 2
Response Rate
90 out of 100
(90%)
50 out of 100
(50%)
Adverse Event Rate
10 out of 100
(10%)
1 out of 100
(1%)
Which medicine would you
prefer?
Prefer 1 Prefer 2
X
15. DCE Choice Task
Give it a Try
Car A Car B
Color Grey Red
Type 4 door sedan 2 door sport
Safety rating 5 stars 3 stars
Your choice
15
16. DCE Choice Task
Now what?
Car A Car B
Color Grey Red
Type 4 door sedan 2 door sport
Safety rating 5 stars 3 stars
Price $20,000 $35,000
Your choice
16
17. Choices Reveal Information about
Preferences
Car A Car B
Color Grey Red
Type 4 door sedan 2 door sport
Safety rating 5 stars 3 stars
Price $20,000 $35,000
Your choice X
17
Something is only of value if we are willing to
give something up for it
18. Utility Estimates
Assumes the
utility associated
with an alternative
or profile is a
function of
observed
characteristics
(attributes levels)
and unobserved
characteristics of
the alternative
18
The utility of each medicine is
the sum of the effect of each level
Utility(Medicine 1) > Utility(Medicine 2)
Prefer 1
X
Prefer 1 Prefer 2
X Prefer 1 Prefer 2
X
Outcome Medicine 1 Medicine 2
Response Rate
90 out of 100
(90%)
50 out of 100
(50%)
Adverse Event Rate
10 out of 100
(10%)
1 out of 100
(1%)
Which medicine would you
prefer?
Prefer 1 Prefer 2
X
19. Using DCEs to Measure Preferences
DCE is a robust quantitative method
grounded in economic theory to measure the
value of alternative choices and risk-benefit
trade-offs for specific attributes
Measure how people value components
(attributes) of a product or service
Eg. For a drug - cost, side effects, delivery mode
Including non-health outcomes
19
20. 20
At the end of this session participants will be able to:
1. Differentiate between patient reported outcome and experience
measures (PROMs and PREMs) and patient preferences
2. Identify and describe good research practices to develop,
design, and execute a patient preferences survey
3. Describe how patient preferences can be measured and how to
interpret the results from patient preferences studies
4. Identify ways in which patient preferences can be applied in
clinical practice for patients with osteoarthritis
Learning Objectives
21. ISPOR Task Forces on Good Research
Practices (GRPs)
https://www.ispor.org/workpaper/ConjointAnalysisGRP.asp
22. 22
ISPOR Task Forces on Good Research
Practices (GRPs)
https://www.ispor.org/workpaper/ConjointAnalysisGRP.asp
“Aligning health care policy with patient preferences
could improve the effectiveness of health care
interventions by improving adoption of, satisfaction
with, and adherence to clinical treatments.”
23. 10-point Checklist for Good Research
Practice in CA in Health
The checklist
generally follows
the steps required
to conduct a
conjoint analysis
study
Attributes
and levels
Define Objective
Design and
implement
survey
instrument
Design
experiment
Analyze data
Report Results
However, some of
these categories
require multiple
steps
24. • Was a well-defined research question stated and
is conjoint analysis an appropriate method for
answering it?
– Was a well-defined research question and/or testable hypothesis
articulated?
– Was the study perspective described and the study placed in any
particular decision-making or policy context described?
– What is the justification for using conjoint analysis to answer the
research question?
Task #1: Defining the Research Question
25. Ranking the importance of attributes
Examining tradeoffs
Estimating willingness to pay
Exploring variation in preferences
– Within a population
– Between two groups of stakeholders
Evaluating potential market share
Possible Research Questions
26. • Were the attributes and attribute levels
supported by evidence?
– Were all important and relevant attributes identified (that is, supported
by literature reviews, focus groups, or other scientific method)?
– Was the choice of included attributes justified and consistent with
theory?
– Were the range and number of levels for each included attribute
justified?
Task #2:
Determining Attributes and Levels
27. Qualitative Work as a Foundation to
Stated Preferences…
- Louviere, Hensher and Swait, 2008
- Lanscar and Louviere, 2008
“We cannot overemphasise how important it is to conduct this kind of
qualitative, exploratory work to guide subsequent phases of the
stated preference study.
“It is highly recommended that qualitative work is conducted during
attribute development…the study team should endeavour to
understand the dimensions…along which the product is evaluated by
consumers and how specific levels of these dimensions are
expressed.”
“There is scope to move beyond simplistic and ad hoc uses of
qualitative tools before, alongside and after quantitative data
collection.”
28. Attributes: Consider all potential attributes, but in context of
plausibility
What attributes are important to people
Number of attributes relevant to research question
Omitted attributes adversely affect study quality
Understand how people discuss attributes
What words or phrases do they use?
Understand any interactions between the attributes
Are attributes considered together?
Does the preference for one attribute depend on the level of another
attribute (e.g. route of drug administration and drug regimen)
Levels: Encompass salient range of values, even if
hypothetical or not currently available
Qualitative Methods for Attribute Development
29. • Was the construction of the conjoint tasks
appropriate?
– Was the number of attributes in each conjoint task
justified?
– Was the number of scenarios in each conjoint task
justified?
– Was the number of conjoint tasks included in the data
collection instrument appropriate?
Task 3 Checklist : Construction of Tasks
30. Survey Development and Administration
30
Qualitative
Research
Pretest
Pilot Test
Data Collection
Conceptual Framework
Identify Key Attributes
Range of Levels
Cognitive Feasibility
Administrative Feasibility
Administration
31. How many Attributes and Levels?
31
# attributes ranged from 3 to 16
70% with 3 to 7 attributes
40-50% included cost as an attribute
# levels ranged from 2 to >6
- Marshall DA et al. The Patient 2010
- deBekker-Grob et al, Health Econ 2010
32. Number of Valuation Tasks Appropriate?
~ 10-20 valuation tasks in a choice set
Aim to:
– Avoid respondent fatigue
– Maximise information per respondent
– Minimise fractional design
32- Marshall DA et al. The Patient 2010
- deBekker-Grob et al, Health Econ 2010
33. • Was the choice of experimental design
justified and evaluated?
• Was the choice of experimental design justified?
• Were alternative experimental designs considered?
• Were the properties of the experimental design
evaluated?
• Was the number of conjoint tasks included in the
date-collection instrument appropriate?
Task #4: Experimental Design
34. Principle of an experiment (the researcher
controls the stimuli):
– To vary one or more attributes with two or
more levels and elicit a behavioural
response
– DCEs systematically vary attributes and
levels to investigate the determinants of
choice in a particular context.
Experimental Design
35. Full Factorial Design (all possible alternatives)
• Product of # Levels for each attribute (grow quickly!)
• 2 attributes with 2 levels =
• 3 attributes with 3 levels =
Factorial Design
36. Full Factorial Design (all possible alternatives)
• Product of # Levels for each attribute (grow quickly!)
• Estimate main effects and all interactions
Fractional Factorial Design (subset of all possible alternatives)
– Select subset randomly (potentially biased unless very large sample size) or
systematically (experimental design) to estimate effects
– May not be able to estimate all interactions
Factorial Design
37. Criteria to Consider Desired Criteria
Correlations among attributes Attributes are independent
Level balance Completely balanced
Number of overlapping attributes Minimal overlap
Efficiency score Higher is better, but relative
Restrictions on implausible
combinations
No implausible
combinations
Cognitive difficulty Low cognitive burden
Complexity to generate design Simple to implement
Considerations in Experimental Design
38. What is the Right Sample Size?
Effect on Estimate Precision
- Johnson FRJ et al. Value in Health, 2013; Yang JC al J Choice Modelling,2015
...precision
varies with the
inverse of the
square root of
sample size.
39. 39
Task 6 Checklist: Instrument Design
• Was the data collection instrument designed
appropriately?
• Was appropriate respondent information collected
(such as sociodemographic, attitudinal, health
history or status, and treatment experience)?
• Were the attributes and levels defined, and was any
contextual information provided?
• Was the level of burden of the data-collection
instrument appropriate? Were respondents
encouraged and motivated?
40. An Example of a Survey Outline
Including a DCE
•Confirming inclusion and exclusion criteriaScreening
•Signed informed consent for face-to-face interviews
•Online informed consent (“I agree to participate”) for online
surveys
Informed consent
•Experience with disease
•Experience with disease treatment and managementBackground questions
•Descriptions of each attribute included in the conjoint tasks
•Warm-up questionsInformation treatment
•8-16 DCE Choice Task questions
•# tasks depends on the number of attributes and levels
•Determined by experimental design
Choice Task questions
•Age, gender, martial status, education, etc.Demographic questions
40
41. 41
Task #7 Checklist: Data Collection
• Was the data-collection plan appropriate?
• Was the sampling strategy justified (for
example, sample size, stratification, and
recruitment)?
• Was the mode of administration justified and
appropriate (for example, face-to-face, pen-
and-paper, web-based)?
• Were ethical consideration addressed (for
example, recruitment, information and/or
consent, compensation)?
42. Mode of Administration
Pen and paper survey by mail
Pen and paper survey in-person
Telephone assisted survey by interviewer
Computer-based survey in person
Television-based survey at home
Internet survey
42
43. • Were statistical analyses and model
estimations appropriate?
• Were respondent characteristics examined and
tested?
• Was the quality of the responses examined (e.g.
Rationality, validity, reliability)
• Was model estimation conducted appropriately?
Task #8 Checklist: Statistical Analysis
44. Data setup
Coding attribute levels – dummy or effects coding
Setting up the data for each choice question
Setting up the data for each respondent
Estimation
Conditional logit (the foundation)
Extensions of conditional logit
Calculations
Marginal rates of substitution (tradeoffs)
Scenario Analysis 44
Analysis Steps
45. The Utility Function
Ui = V(β,Xi ) + εi
where
• V is the value (utility) function
• X is a vector of attribute levels
• β is a vector or parameters (preference weights)
• ε is a random error term
46. Conditional Logistic Regression Analysis
• Main effects
• Assumes relative preferences for each attribute level are
independent of the level of any other attribute in the
profile
• β1*attribute1 + β2*attribute2 + β3*attribute3 + ε
• Interaction effects
• Models preferences for an attribute level as dependent
on the levels of other attributes in the profile
U = …β12*attribute1*attribute2 + β13*attribute1*attribute3 + …
46
47. Marginal Rates of Substitution to Estimate
Risk Benefit Trade-Offs
Indirect utility (value) function:
V = α + β1X1 + β2X2 + β3X3
Marginal rates of substitution:
• - (βk / βj)
•(if X1 and X2 are continuous and linear)
47
48. 10-point Checklist for Good Research
Practice in CA in Health
The checklist
generally follows
the steps required
to conduct a
conjoint analysis
study
Attributes
and levels
Define Objective
Design and
implement
survey
instrument
Design
experiment
Analyze data
Report Results
However, some of
these categories
require multiple
steps
49. 49
At the end of this session participants will be able to:
1. Differentiate between patient reported outcome and
experience measures (PROMs and PREMs) and patient
preferences
2. Identify and describe good research practices to develop,
design, and execute a patient preferences survey
3. Describe how patient preferences can be measured
and how to interpret the results from patient
preferences studies
4. Identify ways in which patient preferences can be applied in
clinical practice for patients with osteoarthritis
Learning Objectives
50. Osteoarthritis Treatment
Benefits and Risks
Category Attributes Levels
Benefits
Ambulatory pain*
None (0mm)
Mild (25mm)
Moderate (50mm)
Severe (75mm)
Resting pain*
Stiffness*
Difficulty doing daily activities*
Risks
Ulcer risk**
None
10 out of 1,000 (1%)
50 out of 1,000 (5%)
100 out of 1,000 (10%)
Stroke risk***
None
5 out of 1,000 (0.5%)
15 out of 1,000 (1.5%)
30 out of 1,000 (3%)
50
Hauber et al., Osteoarthritis Cartilage, 2013
* After treatment, measured on a 100mm visual analog scale
** Incremental treated-related risk in the next year
*** Incremental treatment-related risk in the next 5 years
Benefits - Most important reductions:
- ambulatory pain and difficulty doing daily activities (both: 6.32)
- resting pain (2.80)
- stiffness (2.65)
Risks – Most Important for incremental changes (3%):
- Risk of MI (10.00)
- Stroke (8.90)
51. Surgeon Referral and Wait Times for
Total Joint Replacement
- Marshall DA, Deal K, Conner-Spady B, Bohm E, Hawker G, Loucks, L MacDonald KV,
Noseworthy T. How do Patients Trade-Off Surgeon Choice and Waiting Times for Total
Joint Replacement: A Discrete Choice Experiment. Osteoarthrits and Cartilege
2018;26:522-530.
- Damani Z, Spady C, Nash T, Stelfox T, Noseworthy T, Marshall DA. What is the
influence of single-entry models on access to elective surgical procedures?: A
systematic review. BMJ Open Feb 2017;7(2):e012225.
- Connor-Spady BL, Marshall DA, Hawker GA, Bohm E, Dunbar MJ, Frank C,
Noseworthy T. You’ll know when you’re ready. How do patients decide when the time
is right for joint replacement surgery? BMC Health Services 2014;14:454
- Connor-Spady BL, Marshall DA, Bohm E, Dunbar MJ, Loucks L, Hennigar A, Frank C,
Noseworthy T. Patient factors in referral choice for total joint replacement surgery.
Medical Care 2014;52(4):300-306
53. Next Available Surgeon: Simplified
Example
53
Attributes Levels
Surgeon
reputation
• Excellent
• Good
• Satisfactory
• Don’t know
Surgeon referral
• Selected by you
• Next available surgeon
• Selected by your doctor
Time to surgeon
consultation
• 1 month
• 6 months
• 12 months
• 18 months
Assume all other attributes of surgery (time to surgery and time
to hospital) are the same between options.
*Please note: this example does not use data from the published results (referenced in
previous slides) given the complexity of the full DCE. This is being used as a simplified
example and therefore results do not represent results reported from our published study.
54. Next Available Surgeon:
Simplified Example Choice Task
54
If you were told at the time of referral to a surgeon that these
were the only scenarios available, which one would you choose?
Scenario A Scenario B
Surgeon reputation Excellent Satisfactory
Surgeon referral Selected by you Selected by your doctor
Time to surgeon
consultation
18 months 6 months
I would choose X
55. Next Available Surgeon:
Simplified Results
55
Variable Coefficient P value
Surgeon reputation: excellent
(reference = don’t know)
2.0 <0.001
Surgeon referral: surgeon selected by
you
(reference = selected by your doctor)
0.60 <0.001
Wait time (months) -0.20 <0.001
• Excellent reputation preferred to don’t know reputation
• Surgeon selected by you preferred to surgeon selected
by your doctor
• Shorter wait times are preferred to longer wait times
56. Willingness to Wait for Surgeon with
Excellent Reputation
56
• How long are patients willing to wait to have a
consultation with an excellent surgeon compared to not
knowing their surgeon reputation?
• What does this mean?
Variable Coefficient P value
Surgeon reputation: excellent
(reference = don’t know)
2.0 <0.001
Surgeon referral: surgeon selected by
you
(reference = selected by your doctor)
0.60 <0.001
Wait time (months) -0.20 <0.001
57. Next Available Surgeon:
Willingness to Wait to Select Surgeon
57
• How long are patients willing to wait to select a
surgeon themselves compared to having their doctor
select a surgeon?
• What does this mean?
Variable Coefficient P value
Surgeon reputation: good
(reference = don’t know)
2.0 <0.001
Surgeon referral: surgeon selected by
you
(reference = selected by your doctor)
0.60 <0.001
Wait time (months) -0.20 <0.001
58. Next Available Surgeon:
Attributes and Levels
58
Attributes Levels
Surgeon
reputation
• Excellent
• Good
• Satisfactory
• Don’t know
Surgeon referral
• Selected by you
• Next available surgeon
• Selected by your doctor
Time to surgeon
consultation
• 1 month
• 6 months
• 12 months
• 18 months
Time to surgery
• 1 month
• 6 months
• 12 months
• 18 months
Time to hospital
• 1 hour of less
• More than 1 hour
60. Willingness to Wait to Surgeon
with an Excellent Reputation
Patients are
willing to wait
~10 months
…to see a
surgeon with an
excellent
reputation (vs a
surgeon with a
good reputation)
- Marshall DA et al. Osteoarthritis and Cartilage, 2018
61. Patients with the
worst pain are
willing to wait
~7 months
Patients with the
least pain are
willing to wait
~12 months
…to select the
surgeon themselves
(vs being assigned
the next available
surgeon from a list)
Willingness to Wait to Select Surgeon
verses Next Available Surgeon
- Marshall DA et al. Osteoarthrits and Cartilege, 2018
62. 62
At the end of this session participants will be able to:
1. Differentiate between patient reported outcome and
experience measures (PROMs and PREMs) and patient
preferences
2. Identify and describe good research practices to develop,
design, and execute a patient preferences survey
3. Describe how patient preferences can be measured and how to
interpret the results from patient preferences studies
4. Identify ways in which patient preferences can
be applied in clinical practice for patients with
osteoarthritis
Learning Objectives
63. What is the Future for Arthritis Care
Informed by Patient Preferences ?
1) Support Patient Centered Care and Personalized
Medicine in Clinical Practice
2) Inform Clinical Practice Guidelines
3) Inform Regulatory Decisions about Therapies
63
64. 64
Identify Preference Phenotypes of Patients with
RA for Treatment Based on Benefit-Risk Profiles
Prefer Triple Therapy
Risk averse (rare),
Cost sensitive, oral
Prefer anti-TNF
- Avoid bothersome side effects
Prefer anti-TNF
- Rapid onset of action
- Fraenkel L et al. Ann Rheum Dis, 2017.
Recognising
heterogeneity in
patient
preferences is
important for
choosing
treatment to
achieve best
outcomes for that
individual patient.
65. 2) Using Patient Preferences to Inform Clinical
Practice Guidelines
65
66. Grading of Recommendations Assessment,
Development and Evaluation (GRADE)
66
Considerations in formulating guideline
recommendations (in addition to the quality of
the evidence):
• Tradeoffs between benefits and harms
• Uncertainty in the estimates of effects
• Values and preferences of benefits and harms from
those affected
• Translation of evidence into specific setting
• Resource implications
- GRADE working group. BMJ 2004.
√
√
√
67. Clinical Practice Guidelines: Patient
Preferences Can Differ from Guidelines
- Harrison M et al. BMJ Open 2017
67
- Hazlewood GS et al, Rheumatology, 2016; Hazlewood G et al, J Clin Epi 2018
Treatment preferences of patients with early rheumatoid arthritis:
• On average, patients were risk tolerant, supporting intensive
treatment approaches
• Two classes of patient identified:
a) Patients who were more averse to IV therapies and certain rare risks,
and
b) patients who were highly benefit-driven
Key Messages:
1. There was important heterogeneity in preferences that should
be considered in clinical treatment
2. In contrast to guidelines, many patients with early rheumatoid
arthritis may prefer triple therapy to other treatment options,
a) as initial treatment (78%) or after an inadequate response
to methotrexate (62%)
68. 68
3) Patient Perspectives in Regulatory Decisions
Patient-Focused Benefit-Risk
Analysis to Inform Regulatory
Decisions Value in Health
Themed Issue, October, 2016
- Guest Editor Shelby Reed, Themed Issuue, Value in Health, Oct 2016
Patient-centered movement
Quantitative benefit-risk
69. Canadian Agency for Drugs
and Technology in Health
(CADTH)
Common Drug Review (CDR)
Process for Patient Input
69
CLINICAL
BENEFIT
ECONOMIC
EVALUATION
ADOPTION
FEASIBILITY
PATIENT INPUT
Drug Evaluation
Recommendations based
on
4 main criteria
https://cadth.ca/about-cadth/what-we-do/products-
services/cdr/patient-input
- Klein AV, Hardy S, Lim R, Marshall DA. Regulatory
decision-making in Canada – Exploring new frontiers in
patient involvement. Value in Health, 2016
Health Canada has an established
practice, albeit implicit and often ad
hoc, for including patient
perspectives in both operational and
policy-based regulatory decision-
making.
Value in Health Themed Issue,
October, 2016
Patient-Focused Benefit-Risk
Analysis to Inform Regulatory
Decisions
70. Summary of Patient Preferences in Arthritis
• Preferences measure risk benefit trade offs
• Good Research Practice guidance is available for
designing, conducting and analyzing preferences
• Clinical practice - preferences of patients can be
presented by distinct phenotypes to inform decisions
• Clinical guidelines- incorporating patients’ preferences
into clinical guideline development and
recommendations
• Regulatory Approval – Expect that evidence on
patient’s perspective will be part of the regulatory
approval process in the future.
70
71. 71
Join us in Banff at our Next
DCE Workshop!
Applied Workshop – 3 days
September 9-11, 2019
Using Discrete Choice Experiments in
Health Economics: Theoretical and
Practical Issues
72. Thank you to colleagues and trainees and funders
Arthur J.E. Child Chair Foundation
Canada Research Chair Program
Thank you!
Deborah A Marshall
damarsha@ucalgary.ca
403-210-6377