Protocol writing in clinical research kamalKamal Perera
Perera P.K. Resource person: Workshop on Protocol Writing in Clinical Research: BMARI, Nawinna, Maharagama,Sri Lanka. Organized by: Bandaranaike Memorial Ayurvedic Research Institute (BMARI) Collaboration with World Health Organization 27th January 2015, at Bandaranaike Memorial Ayurvedic Research Institute, Nawinna, Sri Lanka.
Involving patients in research what have we done and how did we do it? Jean R. Slutsky, Patient-Centered Outcomes Research Institute (PCORI) Foredrag, Brukermedvirkning i helseforskning, fra ord til handling. Diakonhjemmet Sykehus 4. november 2014.
This is one of the lectures for the POGS Research Forum in Bacolod, mostly based on the chapter on Clinical Practice Guidelines for Ethics Review from the POGS Research Handbook: The Essentials. I hope this can be a guide for residents who are preparing their research proposal for ethical review.
Patient Engagement in Health Economic and Outcomes Research: Current and Future ISPOR Initiatives, presentation from the ISPOR 20th International meeting Philadelphia, May 2015, by the Patient Centered Special Interest Group
Protocol writing in clinical research kamalKamal Perera
Perera P.K. Resource person: Workshop on Protocol Writing in Clinical Research: BMARI, Nawinna, Maharagama,Sri Lanka. Organized by: Bandaranaike Memorial Ayurvedic Research Institute (BMARI) Collaboration with World Health Organization 27th January 2015, at Bandaranaike Memorial Ayurvedic Research Institute, Nawinna, Sri Lanka.
Involving patients in research what have we done and how did we do it? Jean R. Slutsky, Patient-Centered Outcomes Research Institute (PCORI) Foredrag, Brukermedvirkning i helseforskning, fra ord til handling. Diakonhjemmet Sykehus 4. november 2014.
This is one of the lectures for the POGS Research Forum in Bacolod, mostly based on the chapter on Clinical Practice Guidelines for Ethics Review from the POGS Research Handbook: The Essentials. I hope this can be a guide for residents who are preparing their research proposal for ethical review.
Patient Engagement in Health Economic and Outcomes Research: Current and Future ISPOR Initiatives, presentation from the ISPOR 20th International meeting Philadelphia, May 2015, by the Patient Centered Special Interest Group
Checklist for Preparing a Research Proposal A good resear.docxbissacr
Checklist for Preparing a Research Proposal
A good research proposal should impress someone (e.g., a teacher, a faculty committee, an Institutional
Review Board [IRB], or a funding agency) with the project’s worthiness, feasibility, ethical treatment of
participants and the community, and appropriateness of its design. The following items usually, but not
always, appear in a research proposal.
I. A Title- A title captures the theme or thesis of the proposed project in a nutshell.
II. A Statement of the Project’s Problem or Objective - In this section, you should answer questions
such as
1. What exactly will you study?
2. Why is it worth studying?
3. Does the proposed study have practical significance?
III. Literature Review - In general, a good literature review justifies the pro- posed research.
(See Appendix C for a discussion of literature reviews in research reports. Literature
reviews in research proposals should do the same things that literature reviews in
research reports do.) In a literature review, one normally cites references that appear in
the proposal’s ref- erence section (see later) using a style that is appropriate to one’s
disci- pline (e.g., American Sociological Association style for sociology, American
Psychological Association style for psychology and educa- tion). It is often appropriate to
end the literature review with a state- ment of a research question (or research
questions) or of a hypothesis (or hypotheses) that will guide the research.
The literature review normally accomplishes this goal (of justifica- tion) by addressing
some of the following:
1. What have others said about this topic and related topics?
2. What research, if any, has been done previously on the topic?
3. Have other researchers used techniques that can be adapted for the purposes of the
proposed study?
4. References used
5. Statement of research question or hypothesis
IV. Methods- In a methods section, you should answer questions such as:
1. Whom or what will you study to collect data?
2. How will you select your sample?
3. What, if any, ethical considerations are relevant?
4. What method(s) of data collection will you use—a questionnaire, an interview, an
observation, and/or an available data?
You might also, depending on the nature of the study (e.g., whether it is quantitative or
qualitative), want to answer questions such as
1. What are the key variables in your study?
2. How will you define and measure them?
3. Will you be borrowing someone else’s measures or using a modified form of
measures that have been used before?
4. What kind of data analysis, or comparisons, do you intend to do, or make, with the
data you collect?
V. Plan for Sharing Your Findings- In this section, you will want to answer questions like
these:
1. Will you write up your results in the form of a paper (or book) to be shared with
others?
2. What kinds.
Utilización de la evidencia cualitativa para mejorar la inclusión de las pref...GuíaSalud
Tercera intervención de la Mesa 1 de la Jornada científica GuíaSalud 2017: La implicación de pacientes en el desarrollo de GPC. Una estrategia necesaria para mejorar la toma de decisiones. Simon Lewin
EVB-Evidence Based Practice- principles,purposes,valuechristenashantaram
This brief out the principles,purposes,value involved in EVB-Evidence Based Practice and helps health, scoial care practisioner to know more about the EVB-Evidence Based Practicein health and scocial care international base.
UCSF CTSI Implementation Science Training and Support: Activities and Impacts UCLA CTSI
Dr. Margaret Handley (UCSF) provides the learning goals for this webinar, which are the following: 1) Understand Background ideas that informs the UCSF Implementation Science Training Program, 2) identify components of the conceptual model for Implementation science have been applied to course development, and 3) understand variations of learner experience, ranging from curriculum and examples of completed work.
For more information and to see other dissemination and implementation content, please visit: http://ctsi.ucla.edu/patients-community/pages/dissemination_implementation_improvement
Efforts to place the patient at the center of medical research, spurred by the Affordable Care Act’s founding of the Patient Centered Outcomes Research Institute, have begun to change the way clinical research is conceptualized and conducted. Such efforts hold great promise, but also raise potential challenges for ethical oversight. How should oversight bodies approach the presence of patients in potentially unfamiliar research roles, such as investigator? What forms of patient involvement in research, if any, warrant increased scrutiny from oversight bodies? How do we keep the patient voice from being ‘captured’ by special interest groups? This symposium brought together a diverse group of patients and community members, policymakers, bioethicists, and regulatory officials to address these and other issues.
Patient Engagement for Data Science, Technology & EngineeringCHICommunications
Learn the necessities and relationship between patient engagement and data science, engineering and technology.
Presented by Trish Roche, CHI's Knowledge Translation Practice Lead, this presentation is geared towards professionals in data science looking to hone their skills in patient engagement.
Checklist for Preparing a Research Proposal A good resear.docxbissacr
Checklist for Preparing a Research Proposal
A good research proposal should impress someone (e.g., a teacher, a faculty committee, an Institutional
Review Board [IRB], or a funding agency) with the project’s worthiness, feasibility, ethical treatment of
participants and the community, and appropriateness of its design. The following items usually, but not
always, appear in a research proposal.
I. A Title- A title captures the theme or thesis of the proposed project in a nutshell.
II. A Statement of the Project’s Problem or Objective - In this section, you should answer questions
such as
1. What exactly will you study?
2. Why is it worth studying?
3. Does the proposed study have practical significance?
III. Literature Review - In general, a good literature review justifies the pro- posed research.
(See Appendix C for a discussion of literature reviews in research reports. Literature
reviews in research proposals should do the same things that literature reviews in
research reports do.) In a literature review, one normally cites references that appear in
the proposal’s ref- erence section (see later) using a style that is appropriate to one’s
disci- pline (e.g., American Sociological Association style for sociology, American
Psychological Association style for psychology and educa- tion). It is often appropriate to
end the literature review with a state- ment of a research question (or research
questions) or of a hypothesis (or hypotheses) that will guide the research.
The literature review normally accomplishes this goal (of justifica- tion) by addressing
some of the following:
1. What have others said about this topic and related topics?
2. What research, if any, has been done previously on the topic?
3. Have other researchers used techniques that can be adapted for the purposes of the
proposed study?
4. References used
5. Statement of research question or hypothesis
IV. Methods- In a methods section, you should answer questions such as:
1. Whom or what will you study to collect data?
2. How will you select your sample?
3. What, if any, ethical considerations are relevant?
4. What method(s) of data collection will you use—a questionnaire, an interview, an
observation, and/or an available data?
You might also, depending on the nature of the study (e.g., whether it is quantitative or
qualitative), want to answer questions such as
1. What are the key variables in your study?
2. How will you define and measure them?
3. Will you be borrowing someone else’s measures or using a modified form of
measures that have been used before?
4. What kind of data analysis, or comparisons, do you intend to do, or make, with the
data you collect?
V. Plan for Sharing Your Findings- In this section, you will want to answer questions like
these:
1. Will you write up your results in the form of a paper (or book) to be shared with
others?
2. What kinds.
Utilización de la evidencia cualitativa para mejorar la inclusión de las pref...GuíaSalud
Tercera intervención de la Mesa 1 de la Jornada científica GuíaSalud 2017: La implicación de pacientes en el desarrollo de GPC. Una estrategia necesaria para mejorar la toma de decisiones. Simon Lewin
EVB-Evidence Based Practice- principles,purposes,valuechristenashantaram
This brief out the principles,purposes,value involved in EVB-Evidence Based Practice and helps health, scoial care practisioner to know more about the EVB-Evidence Based Practicein health and scocial care international base.
UCSF CTSI Implementation Science Training and Support: Activities and Impacts UCLA CTSI
Dr. Margaret Handley (UCSF) provides the learning goals for this webinar, which are the following: 1) Understand Background ideas that informs the UCSF Implementation Science Training Program, 2) identify components of the conceptual model for Implementation science have been applied to course development, and 3) understand variations of learner experience, ranging from curriculum and examples of completed work.
For more information and to see other dissemination and implementation content, please visit: http://ctsi.ucla.edu/patients-community/pages/dissemination_implementation_improvement
Efforts to place the patient at the center of medical research, spurred by the Affordable Care Act’s founding of the Patient Centered Outcomes Research Institute, have begun to change the way clinical research is conceptualized and conducted. Such efforts hold great promise, but also raise potential challenges for ethical oversight. How should oversight bodies approach the presence of patients in potentially unfamiliar research roles, such as investigator? What forms of patient involvement in research, if any, warrant increased scrutiny from oversight bodies? How do we keep the patient voice from being ‘captured’ by special interest groups? This symposium brought together a diverse group of patients and community members, policymakers, bioethicists, and regulatory officials to address these and other issues.
Patient Engagement for Data Science, Technology & EngineeringCHICommunications
Learn the necessities and relationship between patient engagement and data science, engineering and technology.
Presented by Trish Roche, CHI's Knowledge Translation Practice Lead, this presentation is geared towards professionals in data science looking to hone their skills in patient engagement.
Similar to Why do we need to incorporate end users’ perspectives when planning new research? (20)
Klara Brunnhuber: Research Waste when Justifying New ResearchCaroline Blaine
Klara Brunnhuber, Vice Chair of EVBRES COST Action on how researchers currently justify a new study and why this lack of a systematic and transparent approach leads to research waste.
Systematicity and transparency when justifying and designing new clinical health studies. Presentation by Simon Kolstoe at the EVBRES Public Meeting in Bergen, 6th February 2019
Hans Lund: Background and Introduction to the COST Action EVBRESCaroline Blaine
Feb 2019: Prof Hans Lund's presentation on the background to what EVBRES is, why it is important and its main aims. See www.evbres.eu for more information.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
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
- 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
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
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 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
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
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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
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
Why do we need to incorporate end users’ perspectives when planning new research?
1. Why do we need to
incorporate end users’
perspectives when
planning new
research?
Klara Brunnhuber
14th September 2022
2. The first trial conducted under
the Nuremberg Military
Tribunals in 1947 became
known as The Doctors' Trial, in
which 20 physicians from the
German Nazi Party were tried
for crimes against humanity for
the atrocious experiments they
carried out on unwilling
prisoners of war and civilians in
occupied countries.
3. Nuremberg Code (1945-1946)
Set of ethical research principles for human experimentation
Principle 2. The experiment should be such as to yield fruitful results
for the good of society, unprocurable by any other methods or means
of study, and not random or unnecessary in nature.
Principle 3. The experiment should be so designed and based on the
results of animal experimentation and a knowledge of the natural
history of the disease or other problem under study that the
anticipated results will justify the performance of the experiment.
4. The guideline defines the scientific
and social value of a study as:
«...generating the knowledge and
the means necessary to protect
and promote people’s health»
• Guideline 1: Scientific and social value
are the fundamental justification for
conducting research that includes
human subjects… …researchers, sponsors, research ethics
committees, and health authorities, must ensure
that proposed studies are
1. Scientifically sound
2. Building on an adequate prior knowledge
base
3. Likely to generate valuable information.
International Guidelines for Ethical
Health-Related Human Research
(first edition in 1949, last revised in 2016)
5. 1. Scientifically sound studies:
1. Internal validity: Trustworthiness of results (and any causal relationship)
1. External validity: Generalisability of results outside the study context
Risk of Bias tool for RCTs Newcastle Ottawa tool for non-RCTs
6. Considering earlier studies in a systematic and transparent way when justifying and designing
new clinical studies:
● Minimises the number of redundant studies to be performed and published – avoiding the
waste of time, resources and money
● Prevents patients from receiving unnecessary placebo, or treatment which is incorrect or
suboptimal – avoiding the waste of health and life.
2. Building on an adequate prior knowledge base:
Placing new results in the context of earlier similar trials in a systematic and transparent way:
● Prevents new results of a single study overshadowing the real results (= based upon all
similar trials including the new study)
● Prevents medical reversal (= the introduction of new interventions in the clinic without real
effect)
● Prevents incorrect recommendations that further studies are still needed and hence the
conducting of new redundant studies.
7. End users: Individuals, communities or organisations outside of academia
that will use or benefit from the results of research*
*Source: Australian Research Council. Engagement and Impact Assessment 2018–19. 2018.
https://dataportal.arc.gov.au/EI/NationalReport/2018/ pages/introduction/index.html?id=background. Accessed 06 Sep 2022.
Key end users of health research include patients, caregivers, and clinicians
3. Generating valuable information - for???
We prefer: End users = individuals, communities or organisations that will
use or be affected by the results of research!
8. Context:
The cha(lle)nging landscape of health research
Research agenda misaligned with the needs of
and not reaching the population it is meant to
serve:
• Often guided by vested researcher
interests
• Research funding does not reflect the
burden of disease on the population
• Difficult to recruit and retain adequate
number of study participants
• Study results hard to disseminate to
patients and to implement in clinical
practice
• Publication bias: ‘Positive’ results more
frequently published, as are studies written
in English or conducted in native English-
speaking countries
• And many more…
Interested in the Future of Research? Check out Elsevier’s future-scoping study at
https://www.elsevier.com/research-intelligence/resource-library/research-futures
9. Incorporating
end users’
perspectives
One possible solution gaining momentum:
Research agenda misaligned with the needs of
and not reaching the population it is meant to
serve:
• Often guided by vested researcher
interests
• Research funding does not reflect the
burden of disease on the population
• Difficult to recruit and retain adequate
number of study participants
• Study results hard to disseminate to
patients and to implement in clinical
practice
• Publication bias: ‘Positive’ results more
frequently published, as are studies written
in English or conducted in native English-
speaking countries
• And many more…
Context:
The cha(lle)nging landscape of health research
10. Two key drivers
Ethical / moral argument:
Manifestation of
democratisation of research
process: those who use and/or
are affected by research
should have a say in what and
how it is done
Consequentialist argument:
Expected benefits for research
quality, efficiency, and impact
(applicability of results to
patients and translation into
clinical practice)
Incorporating
end users’
perspectives
11. Health research
process
(24 reviews)
Health research
design and
delivery
(24 reviews)
Participants
(14 reviews)
Researchers
(11 reviews)
Society / wider
community
(15 reviews)
Patient and
Public
Involvement
(Modigh et al 2021)
Improved identification of study topics and setting of research priorities
• Increased recruitment,
response rates, and
enrolment
• Contribution to data
collection, dissemination
and presentation of results,
and the analysis of data
• Greater rigour in decision-
making
• New skills (research and teamwork
skills) and knowledge (increased
awareness of health issues and the
participant’s illness)
• Personal development: Increased
confidence and self-esteem, and
feeling empowered
• Support (giving and receiving) and
friendship
• Joy and enjoyment (pride, feeling
valued, and making a contribution)
• Increased knowledge and
understanding of the community
(identifying issues the researchers were
not initially aware of, patient perspective
• Increased motivation
• Challenges to beliefs and attitudes
(challenged prejudices and a change of
expectations and assumptions on how
to conduct research with adults with
intellectual disability)
• Increased trust, acceptance,
and credibility of the research
• More sustainable, population-
appropriate and meaningful
interventions, providing
community perspectives
• New and improved
services/practice changes
(improved services for people
with dementia and identified
factors that should be
considered in prevention
programs)
Benefits mentioned
in the literature
14. Challenges and
barriers to incorporate
end users’ perspectives
in research and how to
overcome them
Hans Lund
14th September 2022
15. Manafo 2018 (A systematic review)
“Over the past 10 years, end-user involvement in health research has
emerged as the next evolution in health research.
However, limited knowledge about the clear role and extent of end-
user involvement in health research and the lack of evidence of its
impact have affected the uptake, implementation and ongoing
development of end-user involvement”
16. A number of researchers and
end users have asked important questions
17. Overview of challenges
1. Limited research on the issue
2. The role of end users
3. Implications for the research itself
4. Ethical aspects
5. Challenges for the end users while participating
6. Representation
Based upon a number of systematic
reviews evaluating end user
involvement in research
19. Research on the question of including the
end users’ perspectives in research
1. What is the beneficial effect of end user involvement? For
society - For the research - For the end users
2. What are the harmful effects? For society - For the research -
For the end users
3. How many involve the end-user perspective in their research?
4. How are the end users involved?
5. What are the researchers 'reasons’ for including the end users'
perspectives?
6. When in the research process should the end user be involved?
7. Etc.
20. Research on the question of including the
end users’ perspectives in research
1. What is the beneficial effect of end user involvement? For
society - For the research - For the end users
2. What are the harmful effects? For society - For the research -
For the end users
3. How many involve the end-user perspective in their research?
4. How are the end users involved?
5. What are the researchers 'reasons’ for including the end users'
perspectives?
6. When in the research process should the end user be involved?
7. Etc.
"We are calling for a critical research
agenda for end-user involvement such
as:
1. considers end-user involvement not as an
instrumental intervention, but a social practice of
dialogue and learning between researchers and
the public
2. explores how power relations play out in the
context of end-user involvement in health
research, what "empowerment" means and
whose interests are served by it
3. asks questions about possible harms as well as
benefits of end-user involvement, and whether
the language of influence is useful or not."
21. Regarding “How many involve the end-user
perspective in their research?”
A search for systematic reviews about end users’ involvement in
research identified 107 SRs. Nine of these evaluated the prevalence of
published research incorporating end users’ perspectives.
The median was: 1.75%!!!
22. Research on the question of including the
end users’ perspectives in research
1. What is the beneficial effect of end user involvement? For
society - For the research - For the end users
2. What are the harmful effects? For society - For the research -
For the end users
3. How many involve the end-user perspective in their research?
4. How are the end users involved?
5. What are the researchers 'reasons’ for including the end users'
perspectives?
6. When in the research process should the end user be involved?
7. Etc.
• Interviews
• Focus groups
• Surveys
• Study board
• Advisory council/panel/group
• Regular meeting with
researchers
• Consultants
• Subjects of research
• Panels
• Co-creation / Partnerships
• Newsletter
• Online tools
• Public events
• Steering group
• User forum
• Research team
23. Research on the question of including the
end users’ perspectives in research
1. What is the beneficial effect of end user involvement? For
society - For the research - For the end users
2. What are the harmful effects? For society - For the research -
For the end users
3. How many involve the end-user perspective in their research?
4. How are the end users involved?
5. What are the researchers 'reasons’ for including the end users'
perspectives?
6. When in the research process should the end user be involved?
7. Etc.
• Interviews
• Focus groups
• Surveys
• Study board
• Advisory council/panel/group
• Regular meeting with
researchers
• Consultants
• Subjects of research
• Panels
• Co-creation / Partnerships
• Newsletter
• Online tools
• Public events
• Steering group
• User forum
• Research team
All methods assume the
involvement of an individual
or a group of individuals.
Not any other approach.
For example: use of Qualitative
Evidence Syntheses and / or
systematic reviews of surveys etc.
24. Research on the question of including the
end users’ perspectives in research
1. What is the beneficial effect of end user involvement? For
society - For the research - For the end users
2. What are the harmful effects? For society - For the research -
For the end users
3. How many involve the end-user perspective in their research?
4. How are the end users involved?
5. What are the researchers 'reasons’ for including the end users'
perspectives?
6. When in the research process should the end user be involved?
7. Etc.
• Interviews
• Focus groups
• Surveys
• Study board
• Advisory council/panel/group
• Regular meeting with
researchers
• Consultants
• Subjects of research
• Panels
• Co-creation / Partnerships
• Newsletter
• Online tools
• Public events
• Steering group
• User forum
• Research team
End user involvement:
It is a method not a goal!
Using a method as a goal
limits the range of methods
used for incorporating end
users’ perspectives in
research
25. Research on the question of including the
end users’ perspectives in research
1. What is the beneficial effect of end user involvement? For
society - For the research - For the end users
2. What are the harmful effects? For society - For the research -
For the end users
3. How many involve the end-user perspective in their research?
4. How are the end users involved?
5. What are the researchers 'reasons’ for including the end users'
perspectives?
6. When in the research process should the end user be involved?
7. Etc.
In all phases of research
27. Important factors to consider:
1. End users' actual competence in research
2. Unequal relationship
3. Hierarchy
4. End-user responsibility ("inclusion ladder")
5. Empowerment of end users
6. How to know / collect end users' perspectives,
experiences, values, preferences, concerns?
7. Do end users know why researchers invite them?
29. Consider the following threats
Factors that may affect the conduct and quality of the
research:
1. Unclear goal of involving end users
2. Involvement takes extra time - prolongs the research
process
3. Tokenism problem
4. Scope Creep problem
5. The end users' lack of competence can take an extra-
long time and thus reduce quality
31. Consider the following treaths
As a research subject, there are clear rules for the conditions for
participation in research.
1. What are the ethical aspects of participating as a co-researcher?
2. Does involvement include REC (independent assessment crucial for
good ethical assessment)?
3. What does the legislation say about the involvement of end users -
both for researchers and for end users?
4. What are the ethics / ethical considerations related to Tokenism
5. What are the ethics / ethical considerations related to Scope
Creep?
32. The ethical dimension
“As patient engagement programs continue with uncritical and enthusiastic
support, health ethics must assess the risks and potential harms of such programs.
... the practice of patient engagement fundamentally changes the way we think
about and conduct health research, the impact of which has unknown
consequences for both the patient's well-being and the integrity of health research
... patient engagement is a major social experiment, and the involvement of
patients in activities previously reserved for professionals disrupts the traditional
nature of patient-healthcare relationships»
33. The ethical dimension
“As patient engagement programs continue with uncritical and enthusiastic
support, health ethics must assess the risks and potential harms of such programs.
... the practice of patient engagement fundamentally changes the way we think
about and conduct health research, the impact of which has unknown
consequences for both the patient's well-being and the integrity of health research
... patient engagement is a major social experiment, and the involvement of
patients in activities previously reserved for professionals disrupts the traditional
nature of patient-healthcare relationships»
Ethically, we MUST make
sure that the research is
socially beneficial.
But we cannot implement
this by creating new ethical
dilemmas.
35. Consider these challenges
1. Intellectually challenging and time-consuming
2. Skewed-twisting of competencies (unequal relationship)
3. Locked in a contract - what if the end user is dissatisfied with the
agreement?
4. It is difficult to navigate the different functions and roles that
researchers have among themselves
5. Mismatch between expectations and actual roles
6. The discomfort of perhaps affecting research negatively
7. Many hours - what about expense coverage / salary? And what does it
mean for the input quality if you are paid (does it give what the
researchers want?)
37. Consider these challenges
1. Can "lived experience" be representative?
2. Must there be a democratic process for selection? If so,
who can you choose from?
3. How are the end users recruited? Those that the
researchers know? The ones they have easy access to?
Same end user in several different studies (professional
end users)?
4. Advertising: who is responding to the ad?
5. Etc.
39. The common characteristics of most of these
challenges
There is an assumption that specific, concrete
individuals / groups of individuals must be identified
and included.
But that is making one possible method the goal!
40. Our aim ...
... in incorporating end users’ perspectives, experiences, concerns,
values and preferences is to produce
Societal and relevant research
Further:
The process of obtaining end users’ perspectives, experiences,
concerns, values and preferences must be
Scientific, systematic, and transparent
and not random, opaque, and tokenistic
41. We suggest to use an evidence-based
approach
Evidence-Based Research (EBR)
Research on research has shown that because researchers do NOT
systematically review previous research in their field, wasteful and
indifferent research is produced!
We have established an international organization (EBR Network) that
seeks to promote the use of a systematic and transparent approach
when researchers justify and design new studies.
42. We suggest to use an evidence-based
approach (2)
But it is only one leg - the rationale and design of new studies must
stand on 2 legs:
Research must be valuable: only carried out because there is a
knowledge gap AND because there is a need among the end uses
It is time for the end users' perspective to be taken into account when
research is planned, carried out and published.
43. Therefore ...
Researchers MUST include
the end-users’ perspectives when planning,
performing and disseminate research
- but it must be done in a scientific,
systematic and transparent way.
44. 1st requirement
Scientific approach
End users need to inspire researchers to look at important and socially important issues.
Researchers must know and be in dialogue with end users - continuously
Use of systematic overviews of previous similar research & qualitative
studies that include the end users' perspective
"Qualitative systematic overviews enable the perspectives and experiences of several
stakeholder groups from different contexts to be assessed and represented in a
systematic and transparent manner"
45. 2nd requirement
Ethical involvement
It requires the development of legislation that ensures that end users
are involved on an equal footing with the researchers themselves.
Perhaps REC can also look at the way end users are involved in planned
projects, to ensure independent assessment.
Legislation must ensure that tokenism is avoided,
but also that "scope creep" is avoided.
46. 3rd requirement:
IF you need to involve individuals/groups, then
1. Have a clear purpose, role and structure to engage patients
2. Initiate and maintain partnerships between researchers and stakeholders
3. Take the time required to promote relationship building as the most critical component of
establishing trust
4. Have a clear leadership from the lead researcher and / or broader culture of involvement
5. Promote the need for facilitation of cross-communication among all groups involved in the
project
6. Optimize end-user perspectives across all phases of research
7. Ensure meaningful end-user influence on research by demonstrating the need for respect and
support for end-users
8. Ensure adequate training for researchers and end users
9. Share and promote research learning, including evaluation efforts
47. Conclusion
1. Involvement of end users is crucial for valuable research
2. End user involvement is not a goal but a method for performing
relevant and important research
3. We must use a scientific approach to incorporate end users’
perspectives in research: systematic reviews of qualitative studies
4. We must find solutions to the unanswered ethical challenges
5. We must show respect and consider the many practical challenges
when we involve individuals / groups of individuals in research
51. What does the Evidence say? (Modigh et al 2021)
Patient and
public
involvement
A scoping review of reviews on the impact of
PPI in health research and healthcare:
• Definition of PPI: “Research being carried
out ‘with’ or ‘by’ members of the public
rather than ‘to’, ‘about’ or ‘for’ them”
• Search date: March 2020
• Databases: Web of Science, Scopus,
Medline/Pubmed and Cochrane Library
• Included studies: English-language studies
published from 2020 that reviewed the
literature on the impact of PPI activities on
health research and healthcare
52. What does the Evidence say? (Modigh et al 2021)
Patient and
public
involvement
53. What does the Evidence say? (Modigh et al 2021)
Patient and
public
involvement
Results:
• 888 studies included in 24 reviews for health
research alone; 69 studies in 3 reviews for
health research and healthcare
Country % studies of 888
(health research
alone)
% studies of 69
(health research
& healthcare)
UK 54% 50%
USA 15% 26%
Canada 8% 6%
Australia 5% 4.5%
Netherlands 3% 4.5%
South Africa 2.5%
India 3%
Other countries 12.5% 6%
Quality # Health research
alone
#Health research
and healthcare
Significant deficiencies 10 2
Continued uncertainty about
the evidence for impact
14 3
Overlap between two 7 2
54. Impact on Number of
reviews
Positive Impact Negative Impact
Health research
process
24 Improved identification of study topics and setting of research priorities
Health research
design and
delivery
24 • Increased recruitment, response rates, and enrolment
• Contribution to data collection, dissemination and presentation of
results, and the analysis of data
• Greater rigour in decision-making
• More time consuming and more
costly
• Scientific and ethical conflicts
• Downgraded methodological
standards
Participants 14 • New skills (research and teamwork skills) and knowledge (increased
awareness of health issues and the participant’s illness)
• Personal development: Increased confidence and self-esteem, and
feeling empowered
• Support (giving and receiving) and friendship
• Joy and enjoyment (pride, feeling valued, and making a contribution)
• Frustration
• Powerlessness
• Marginalisation
• Distress
• Demanding workload
• Lack of control
Researchers 11 • Increased knowledge and understanding of the community (identifying
issues the researchers were not initially aware of, patient perspective
• Increased motivation
• Challenges to beliefs and attitudes (challenged prejudices and a change
of expectations and assumptions on how to conduct research with
adults with intellectual disability)
• Power struggles
• Experiences of the process
being lengthy and demanding
• Coordination challenges
Society / wider
community
15 • Creating trust and acceptance of the research (increased trust,
acceptance, and credibility of the research)
• Keeping projects grounded and focused on benefits for the community
(more sustainable, population-appropriate and meaningful interventions,
providing community perspectives)
• New and improved services/practice changes (improved services for
people with dementia and identified factors that should be considered in
prevention programs)
Inclusion of irrelevant community
input