This document outlines the key elements in designing a clinical research study, including the anatomy and physiology. The anatomy refers to the components that make up a study, such as the research question, study design, subjects, variables, and statistical analysis plan. Developing a clear research question using PICO (patients, intervention, comparison, outcomes) criteria is important. Study designs could include observational studies like cohorts or randomized controlled trials. The physiology aspect refers to how the study functions to draw valid conclusions about outcomes in the target population. Sample size calculations help determine how large the study needs to be. Accounting for biases and errors strengthens the research.
Clinical Research for Medical StudentsAhmed Negida
This presentation discusses (1) the importance of clinical research to medical students, (2) barriers towards student research, and (3) how to select a good mentor.
Clinical Research for Medical StudentsAhmed Negida
This presentation discusses (1) the importance of clinical research to medical students, (2) barriers towards student research, and (3) how to select a good mentor.
For a School of Information class on medical librarianship, this presentation was created to provide a very basic introduction and overview of the concepts, expectations, and experience of the librarian portion of working in a systematic review team.
Presentation is A Guide to Scientific Writing of a Research Protocol. Research proposal or protocol is a planning to conduct research , a issue to address or a research problem to find an answer. This presentation help researcher to systematically plan the research. The presentation details every step in research planning and the technical expectations in steps.
Evidence-Based Medicine - Overview
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Measuring what we want to measure, Liz Norman ANZCVS 2013Liz Norman
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One of the challenges of any examination system is measuring the knowledge skills and judgements that we think are important indicators of achievement. This session will focus on designing and communicating tasks for candidates that let them demonstrate their knowledge, skills and judgement. It will look at different types of questions, including where MCQs fit in, and what to think about when writing them.
Liz Norman is a graduate of the University of Sydney who worked in private small animal practice for several years before moving to practice at the University of Melbourne and then the University of Glasgow. She took up an academic position at Massey University in 2001 and is Director of the distance Master of Veterinary Medicine programme. Liz received a national Tertiary Teaching Excellence Award for sustained excellence in 2012 and is currently a Doctoral candidate in Education, researching assessment practices. She has held a position on the Board of Examiners of the Australian College of Veterinary Scientists for 9 years, including 5 years as Assistant Chief Examiner and has been involved in all aspects of the College examination system.
A session for the Dent 610 course at the University of Michigan, on research methods and processes. Specific focus of this session on systematic review methods and processes, especially through database searching.
A well recognised form of research is called systematic reviews on specific point. Why do we need them and How they can be done?? this talk is trying to answer these questions in a simple way
Research brief showing results from a global survey of current trends in concept design.
We heard from designers, team and process managers, and even company and business leaders. Find out what they said about concept design in this research brief.
Visit the Concept Design Resource Center to better understand the common challenges related to concept design and how to improve them: http://www.ptc.com/solutions/concept-design/?utm_source=SlideShare&utm_medium=ConceptDesignWP&utm_campaign=Social%2B
For a School of Information class on medical librarianship, this presentation was created to provide a very basic introduction and overview of the concepts, expectations, and experience of the librarian portion of working in a systematic review team.
Presentation is A Guide to Scientific Writing of a Research Protocol. Research proposal or protocol is a planning to conduct research , a issue to address or a research problem to find an answer. This presentation help researcher to systematically plan the research. The presentation details every step in research planning and the technical expectations in steps.
Evidence-Based Medicine - Overview
- How to be a good doctor - A step in Health promotion
- By Ibrahim A. Abdelhaleem - Zagazig Medical Research Society (ZMRS)
Measuring what we want to measure, Liz Norman ANZCVS 2013Liz Norman
Measuring what we want to measure: writing excellent questions for College examinations. Plenary lecture at the Australian and New Zealand College of Veterinary Scientists Science Week meeting, 2013
One of the challenges of any examination system is measuring the knowledge skills and judgements that we think are important indicators of achievement. This session will focus on designing and communicating tasks for candidates that let them demonstrate their knowledge, skills and judgement. It will look at different types of questions, including where MCQs fit in, and what to think about when writing them.
Liz Norman is a graduate of the University of Sydney who worked in private small animal practice for several years before moving to practice at the University of Melbourne and then the University of Glasgow. She took up an academic position at Massey University in 2001 and is Director of the distance Master of Veterinary Medicine programme. Liz received a national Tertiary Teaching Excellence Award for sustained excellence in 2012 and is currently a Doctoral candidate in Education, researching assessment practices. She has held a position on the Board of Examiners of the Australian College of Veterinary Scientists for 9 years, including 5 years as Assistant Chief Examiner and has been involved in all aspects of the College examination system.
A session for the Dent 610 course at the University of Michigan, on research methods and processes. Specific focus of this session on systematic review methods and processes, especially through database searching.
A well recognised form of research is called systematic reviews on specific point. Why do we need them and How they can be done?? this talk is trying to answer these questions in a simple way
Research brief showing results from a global survey of current trends in concept design.
We heard from designers, team and process managers, and even company and business leaders. Find out what they said about concept design in this research brief.
Visit the Concept Design Resource Center to better understand the common challenges related to concept design and how to improve them: http://www.ptc.com/solutions/concept-design/?utm_source=SlideShare&utm_medium=ConceptDesignWP&utm_campaign=Social%2B
How to scientifically conduct a clinical professional research trial? In the current era of Collaborate or parish, we need to keep this design in our mind.
Enjoy
@copyLeft
FPS School Committee Presentation - Mar 10, 2015Franklin Matters
The document scheduled for presentation to the Franklin School Committee at their meeting March 10, 2015. The presentation was scheduled earlier this year and rescheduled due to the blizzard.
To understand why a study abstract is important to scientific communication.
To understand the process by which abstracts are selected for presentation at scientific conferences.
To learn the features which unite successful abstract submissions.
Biostatistics is one of the most unavoidable area in the modern day practice of evidence based medicine . In the ppt , trying to give a glimpse on how a clinician should approach Biostatistics
This presentation by Morris Kleiner (University of Minnesota), was made during the discussion “Competition and Regulation in Professions and Occupations” held at the Working Party No. 2 on Competition and Regulation on 10 June 2024. More papers and presentations on the topic can be found out at oe.cd/crps.
This presentation was uploaded with the author’s consent.
0x01 - Newton's Third Law: Static vs. Dynamic AbusersOWASP Beja
f you offer a service on the web, odds are that someone will abuse it. Be it an API, a SaaS, a PaaS, or even a static website, someone somewhere will try to figure out a way to use it to their own needs. In this talk we'll compare measures that are effective against static attackers and how to battle a dynamic attacker who adapts to your counter-measures.
About the Speaker
===============
Diogo Sousa, Engineering Manager @ Canonical
An opinionated individual with an interest in cryptography and its intersection with secure software development.
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UIIN Conference, Madrid, 27-29 May 2024
James Wilson, Orkestra and Deusto Business School
Emily Wise, Lund University
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This presentation, created by Syed Faiz ul Hassan, explores the profound influence of media on public perception and behavior. It delves into the evolution of media from oral traditions to modern digital and social media platforms. Key topics include the role of media in information propagation, socialization, crisis awareness, globalization, and education. The presentation also examines media influence through agenda setting, propaganda, and manipulative techniques used by advertisers and marketers. Furthermore, it highlights the impact of surveillance enabled by media technologies on personal behavior and preferences. Through this comprehensive overview, the presentation aims to shed light on how media shapes collective consciousness and public opinion.
Supercharge your AI - SSP Industry Breakout Session 2024-v2_1.pdf
Study Design Tridandapani 2016
1. Anatomy and Physiology of
Clinical Research
Srini Tridandapani, PhD MD
Department of Radiology and Imaging
Sciences
Emory University
2. Goal
• To understand the anatomy and physiology
of clinical research, i.e., understand the
principles of study design, analysis,
reporting and bias
3. Learning Objectives
At the end of this lecture you should be able
• To enumerate the various elements of a
research study
• To describe how the elements of the a
research study interact
• To name the two major classes of error in
research studies
4. Clinical Research
• Anatomy: What it’s
made of…
– Research question
– Design
– Subjects
– Measurements
– Sample size calculation
• Physiology: How it
works…
– Make valid inferences
– What happened in the
study sample
– How does it generalize
to the world outside
– How to errors,
random and systematic
6. Anatomy: Outline of Study
Protocol
Element Purpose
Research Questions What questions will the study address?
Background and Significance Why are these questions important?
Design
(Time frame, epidemiologic approach)
How is the study structured?
Subjects
(Selection criteria, sampling design)
Who are the subjects and how will they
be selected?
Variables
(Predictor variables, confounding
variables, outcome variables)
What measurements will be made?
Statistical issues
(Hypotheses, sample size, analytic
approach)
How large is the study and how will it
be analyzed?
7. Anatomy: Outline of Study
Protocol
Element Purpose
Research Questions What questions will the study
address?
Background and Significance Why are these questions important?
Design
(Time frame, epidemiologic approach)
How is the study structured?
Subjects
(Selection criteria, sampling design)
Who are the subjects and how will they
be selected?
Variables
(Predictor variables, confounding
variables, outcome variables)
What measurements will be made?
Statistical issues
(Hypotheses, sample size, analytic
approach)
How large is the study and how will it
be analyzed?
8. Research Question
• Objective of the study
• Starts as a general question, but must be
narrowed down to a concrete, researchable
issue
• Example:
– Should people eat more fish?
9. Research Question
• Break this question into more specific
components:
– How often do Americans eat fish?
– Does eating fish the risk of CV disease?
– Is there a risk of mercury toxicity from fish
intake in older adults?
– Do fish oil supplements have the same effects
on CV disease as dietary fish?
– Which fish oil supplements don’t make people
smell like fish?
10. A well-formatted research question:
The four PICO elements
P patients
I intervention
(independent variable)
C comparison
O outcome
(dependent variable)
• S subjects
• E exposure
• C comparison
• O outcome
11. Using PICO to develop a question
Includes each of the following:
• Intended patients/subjects to study
• The independent variable of interest
– Intervention, exposure, pt characteristic
– The item of primary interest of the study
• Comparison group or procedure
• Outcome measure
Combines them together as a question
12. Question example
• Issues to address:
– Define CHD
– Define study population sample source
– Define fish intake
Final result:
Among a sample of patients seen in the investigator’s
clinic who have a previous CHD diagnosis and
respond to a mailed questionnaire, what proportion
report taking fish oil supplements?
14. Research question comments
• It has been proposed that if your entire
question can be stated in one breath, it is too
short
• That is extreme. It need not include your entire
inclusion and exclusion criteria
• The research question is analogous to the pt
chief complaint. It is not the entire history and
exam.
15. Refine the Research Question:
Make it a FINER question
• Feasible = can it be done with the resources
that are available?
• Interesting = do you have passion for it?
• Novel = is it a new research idea?
• Ethical = does it comply with research ethics
and codes of conduct?
• Relevant = does it pass the “so what” test?
16. Applying the FINER criteria
• Carefully review your proposed research question
– Research in progress meetings can be helpful for this
• Consider how it meets each of the FINER
criteria……or not
Then decide:
• Do you still want to proceed with your proposed
project? Is it feasible, etc.?
17. The FINER review
This is where most good research
questions die an early death
(or should have died)
18. Anatomy: Outline of Study
Protocol
Element Purpose
Research Questions What questions will the study address?
Background and Significance Why are these questions important?
Design
(Time frame, epidemiologic approach)
How is the study structured?
Subjects
(Selection criteria, sampling design)
Who are the subjects and how will they
be selected?
Variables
(Predictor variables, confounding
variables, outcome variables)
What measurements will be made?
Statistical issues
(Hypotheses, sample size, analytic
approach)
How large is the study and how will it
be analyzed?
19. Background and Significance
• Provide context and Rationale
• References, including your own work (toot
your horn!...but not too loudly)
• Be succinct! Need to pare this down with
new NIH format
20. Anatomy: Outline of Study
Protocol
Element Purpose
Research Questions What questions will the study address?
Background and Significance Why are these questions important?
Design
(Time frame, epidemiologic
approach)
How is the study structured?
Subjects
(Selection criteria, sampling design)
Who are the subjects and how will they
be selected?
Variables
(Predictor variables, confounding
variables, outcome variables)
What measurements will be made?
Statistical issues
(Hypotheses, sample size, analytic
approach)
How large is the study and how will it
be analyzed?
21. Design of Study
Observational Study
• Cohort study
– Retrospective
– Prospective
• Cross-sectional study
• Case-control study
Clinical Trial
• Randomized blinded trial
– Can also have nonrandomized
or un-blinded designs
22. Anatomy: Observational Designs
Study Design Key Feature Example
Cohort Study A group followed over
time
Measure fish intake at
baseline and periodically
examine subjects at fu
visits to see if eating more
fish CHD events
Cross sectional study A group examined at one
point in time
Interview subjects about
current and past history of
fish intake and correlate
with h/o CHD and current
coronary calcium score
Case-control study Two groups selected
based on the presence or
absence of an outcome
Examine a group of
patient w/ CHD (“cases”)
and compare them with
group who did not have
CHD (“controls”), asking
about past fish intake
23. Anatomy: Clinical Trial Design
Study Design Key Feature Example
Randomized Blinded
Trial
Two groups created by a
random process, and a
blinded intervention
Randomly assign subjects
to receive fish oil
supplements or placebo,
then follow both
treatment groups for
several years to observe
the incidence of CHD
24. Anatomy: Outline of Study
Protocol
Element Purpose
Research Questions What questions will the study address?
Background and Significance Why are these questions important?
Design
(Time frame, epidemiologic approach)
How is the study structured?
Subjects
(Selection criteria, sampling design)
Who are the subjects and how will
they be selected?
Variables
(Predictor variables, confounding
variables, outcome variables)
What measurements will be made?
Statistical issues
(Hypotheses, sample size, analytic
approach)
How large is the study and how will it
be analyzed?
25. Anatomy: Study Subjects
• Inclusion and Exclusion Criteria defining
target population
• How best to recruit
26. Anatomy: Study Subjects
• In the Fish Study example, how is CHD
defined?
– Could be subjects seen in the clinic with
diagnosis codes for MI, angioplasty, or CABG
in their EMR
• Recruitment Trade-off
– Using random sample of CHD patients in the
entire country would enhance generalizability
but more expensive
27. Anatomy: Outline of Study
Protocol
Element Purpose
Research Questions What questions will the study address?
Background and Significance Why are these questions important?
Design
(Time frame, epidemiologic approach)
How is the study structured?
Subjects
(Selection criteria, sampling design)
Who are the subjects and how will they
be selected?
Variables
(Predictor variables, confounding
variables, outcome variables)
What measurements will be made?
Statistical issues
(Hypotheses, sample size, analytic
approach)
How large is the study and how will it
be analyzed?
28. Variables
• Predictor variables
– Age, race, sex, smoking history, fish and fish
oil supplement intake
• Outcome variables
– Heart attacks, strokes, quality of life,
unpleasant odor
• Confounder variables
– Other predictors of outcome such as intake of
red meat or income level that could be related
to dietary fish and confuse interpretation
29. Anatomy: Outline of Study
Protocol
Element Purpose
Research Questions What questions will the study address?
Background and Significance Why are these questions important?
Design
(Time frame, epidemiologic approach)
How is the study structured?
Subjects
(Selection criteria, sampling design)
Who are the subjects and how will they
be selected?
Variables
(Predictor variables, confounding
variables, outcome variables)
What measurements will be made?
Statistical issues
(Hypotheses, sample size, analytic
approach)
How large is the study and how will it
be analyzed?
30. Anatomy: Statistical Issues
• Consult a Statistician
• Develop a sound statistical hypothesis
(different from a scientific hypothesis)
• Reframe research question to test for
statistical significance of findings
• Hypothesis allows calculation of sample
size
31. Anatomy: Statistical Issues
• Reframe scientific into a statistical
hypothesis
• Hypothesis: 50- to 69-year-old women with
CHD who take fish oil supplements will
have a lower risk of myocardial infarction
than those who do not
34. Inferences
Truth in the
Study
Study
Plan
Truth in the
Universe
Research
Question
Infer Findings in the
Study
Actual
Study
Infer
Design Implement
EXTERNAL
VALIDITY
INTERNAL
VALIDITY
DESIGNING AND IMPLEMENTING
DRAWING CONCLUSIONS
35. Designing the Study
• What is the prevalence of regular use of fish
oil supplements among people with CHD?
• Among a sample of patients seen in the
investigator’s clinic who have a previous
CHD diagnosis and respond to a mailed
questionnaire, what proportion report taking
fish oil supplements?
36. Design Errors
Truth in the Study
Study Plan
Truth in the Universe
Research Question
EXTERNAL
VALIDITY
Infer
Design
Errors
38. Types of Errors
• Systematic Errors (Bias)
• Random Errors (Chance) – this can be
reduced by increasing the sample size
39. Summary of the Physiology of
Clinical Research: How it Works
Truth in the
Universe
Research
question
Infer
Design
INTERNAL
VALIDITY
Truth in the
Study
Study
Plan
Findings in the
Study
Actual
Plan
Infer
Design
EXTERNAL
VALIDITY
Random
and
Systematic
Errors
Random
and
Systematic
Errors
40. Summary
• Anatomy of research: what it’s
made of
• Physiology of research: how it
works
• Research ? study plan actual
study
