RHSC 500: Course Introduction

& Intro to Quantitative Research

Lecture 1
September 8, 2020
Teresa Liu-Ambrose
 Instructors
 Course Coordinator & Co-Instructor: Dr.
Teresa Liu-Ambrose
 Co-Instructor: Dr. Laura Nimmon
 Librarian: Charlotte Beck
 Introductions
 Name and where you are from
 Prior educatiom
 Current program: MSc or PhD
 Supervisor
 Any background with research methods
 One fun fact?
 Today’s Agenda
 Course Overview (15 mins)
 What is Research?: Types and Design (30
mins)
 Research Ethics (30 mins)
 Ethics Tutorial & Course (5 mins)
 Identifying the Research Question (30 mins)
 Finding the Evidence: Charlotte Beck (30
mins)
 Course Overview
 Course Syllabus
 Pre-readings: Provide background to lectures
 For efficiency, preview lecture notes and target
those content in the pre-readings
 Required textbook + articles
 Due dates
 Evaluations
 Canvas
 Lecture slides
 Articles (Library Online Course Reserves)
Check Syllabus & Canvas regularly
Evaluations: Page 2 of Syllabus
 Outside the Classroom
 Contact Information
 teresa.ambrose@ ubc.ca
 3450F, 3rd floor Djavad Mowafaghian Centre
for Brain Health
 Office Hours by Zoom
 Please email to arrange
 Expectations
 Be prepared and be engaged
 Attendance
 Assignments are to be handed in on time
 Grammar and spelling
 10% of mark received may be deducted (in
addition to deduction for late submission, if
applicable)
 Today’s Agenda
 Course Overview (15 mins)
 What is Research?: Types and Design (30
mins)
 Research Ethics (30 mins)
 Ethics Tutorial & Course (5 mins)
 Identifying the Research Question (30 mins)
 Finding the Evidence: Charlotte Beck (30
mins)
 Learning Objectives
 Be introduced to different types of
research
 Define internal vs. external validity
Read scientific publications and be able to:
 Identify the basic study design used
 Broadly rank their level (i.e., strength) of
evidence
 What is Research?
 Research is a systematic way of asking
questions and discovering information that
relies on an orderly method of inquiry
known as the scientific method.
 Ottenbacher, 1986
Scientific Method
 Research is Non-Linear
 Scientific process is:
 Iterative
 Dynamic, flexible, unpredictable
 Influenced by technology, serendipity,
motivation, curiosity,
 All ideas are tested with evidence
 Verified by scientific community
 Types of Research
 Basic research
 Clinical/applied research
 Translational research
 Quantitative
 Qualitative
 Basic Research
 Fundamental or bench research
 Foundation of knowledge for
clinical/applied research
 Laboratory studies with cell cultures,
animal studies, or physiological
experiments.
 Clinical/Applied Research
 Research conducted with human subjects
or with human tissue
 Functional applications
 Testing theories that influence practice,
guidelines, recommendations, etc.
 Translational Research
 Application of basic research findings to
clinically relevant issues (“bench to
bedside”).
 Quantitative Research
 Precise measuring outcomes using
numerical data under standardized
conditions
 Relationships between variables
 Inferences from samples to populations
 Causation
 A key focus in quantitative research
 Variable of interest which produces an
effect, or gives rise to an action,
phenomenon, or condition
 Qualitative Research
 Narrative description of a phenomenon
 Meaning, context, process
 Inductive theory development
 Discovering unanticipated outcomes
 Research Design
 Can be described according to several
types of design characteristics
 Basic/broad classification:
 True Experimental: Researcher actively
intervenes to change circumstances and
observes the consequences
 Non-Experimental: Researcher collects data
but does not alter circumstances or intervenes
 Research Design
 Best viewed as a continuum
Non-
Experimental
Experimental
• Description & • Cause & Effect
Associations • Prospective
• Retrospective
• Prospective
Level of Evidence
 Levels of Evidence
Evidence of
Causality/Reduced
Bias

Hypothesis
Generating/High Bias
Sackett’s Levels of Evidence
 Internal Validity
 The degree to which the relationship
between the independent and dependent
variable is free from the effects of
extraneous factors.
 Did the treatment cause the observed
changes or was there another factor
responsible for the change?
 Internal validity increases with greater degree
of experimental control
 External Validity
 The extent to which results of the study
can be generalized outside of the
experimental situation.
 Such as can the treatment studied be easily
adopted and utilized by clinicians
 Internal vs. External Validity
 To achieve a high level of internal validity,
researchers maximize experimental
control
 Consequently, external validity is
threatened because the results are less
applicable to the ‘real’ world
 Today’s Agenda
 Course Overview (15 mins)
 What is Research?: Types and Design (30
mins)
 Research Ethics (30 mins)
 Ethics Tutorial & Course (5 mins)
 Identifying the Research Question (30 mins)
 Finding the Evidence: Charlotte Beck (30
mins)
 Learning Objectives
 Identify and define the three guiding
principles in protecting human rights in
clinical research
 Identify and discuss the two key elements
of the informed consent process
 Gain an understanding of the ethical
conduct for clinical research through:
 TCPS 2 (October 6, 2020)
 Responsible Conduct of Research Course
(December 1, 2020)
 Boundary Between Practice &
Research: Ethical Considerations
 Intent: Individual clients vs. new knowledge
development
 Innovation: Differs from customary practice
 Plan: Level of control and uniformity

 Research....done with the intent of developing

new knowledge and which differs in any way
from custom medical practice….identified by
virtue of the fact that it is conducted according to
a plan.
(Belmont Report, 1975)
 Be Aware
 Some may be overly optimistic about the
prospects of an experimental intervention
and overstate potential benefits or
understate foreseeable risks to
prospective participants.
 This can foster therapeutic misconception
among patients and influence the
recruitment and consent process.
 Be Aware
 Clinicians must take care not to create
unrealistic expectations among
participants with respect to the potential
benefits of the research
 Should take all necessary measures to
separate their role as researcher from their
role as clinician (e.g., recruitment,
obtaining consent).
 TCPS Chapter 11
 Clinical Research:
Guiding Principles
 Autonomy
 Self-determination
 Includes: disclosure, comprehension,
voluntariness, and competence
 Beneficence
 Obligation to attend to the well-being of
individuals
 “Do no harm” (i.e., non-maleficence)
 “Maximize possible benefits and minimize possible
harm”
 Clinical Research:
Guiding Principles
 Justice
 Fairness in the research process, or the
equitable distribution of the benefits and
burdens
 Informed Consent
 Most important ethical tenet in human
studies is the individuals’ ability to agree to
participate with full understanding of what
will happen to them
 Addresses the basic principals of
autonomy, beneficence, and justice
 Informed Consent: Key
Components
 Information Elements
 Risk
 Benefits
 Confidentiality
 How will one protect and safeguard information
 Lay language
 Range of motion, manual therapy, eccentric
exercise, proprioceptive training, etc.
 Researcher must offer to answer questions at
any time
 Informed Consent: Key
Components
 Consent Elements
 Voluntary
 Not allowed to coerce patients; no penalty; no
change to their care
 Must allow adequate time for potential participants
to make their decision
 Clinician wearing the researcher hat
 Freedom to withdraw at anytime
 Competence and comprehension
 Consent vs. assent
 Independent Review:
Institutional Review Boards
 As a rule, institutions require that all
projects involving human subjects must be
submitted for review
 Institutional Review Boards
 At least five members
 Ensure compliance with the ethical principals
and regulations
 Consider the risk-benefit ratio
 IRB: UBC and VCHRI
(Resource Slide)
 UBC Website: https://rise.ubc.ca
 Human Subjects
 Clinical Research Ethics Board (REB)
 Behavioural REB

 VCHRI Website: http://www.vchri/ca

 Request for Approval to Conduct Research
 Summary:
Ethical Principals in Research
 Requirement for free and informed
consent
 Respect for vulnerable persons
 Respect for privacy and confidentiality
 Respect for justice and inclusiveness
 Balancing harms and benefits
 Minimizing harms
 Maximizing benefits
 Today’s Agenda
 Course Overview (15 mins)
 What is Research?: Types and Design (30
mins)
 Research Ethics (30 mins)
 Ethics Tutorial & Course (5 mins)
 Identifying the Research Question (30 mins)
 Finding the Evidence: Charlotte Beck (30
mins)
 Tri-Council Policy Statement (TCPS):
Ethical Conduct for Research Involving
Humans
 Describes the policies of the major
research funding agencies in Canada
 Funding will be provided to individuals and
institutions that certify that they comply
with this Policy regarding research
involving human subjects.
 http://www.pre.ethics.gc.ca
 TCPS Tutorial
 If you have previously completed the
TCPS 2 (2018)*, you can just reprint the
certificate
 *As of June 2019, TCPS 2 (2018) replaced
TCPS 2 (2014)
 Instructions posted on Canvas
 TCPS Tutorial
 The TCPS tutorial can be accessed at:
http://tcps2core.ca/welcome and click on
“Login to Core/Create Account”.
 The average amount of time required for
this exercise is ~ 3 hours.
 Please give yourself sufficient time to
register and print; website can be very
finicky
 Responsible Conduct of
Research (RCR) Course
 https://grad-postdoc.med.ubc.ca/current-
students/research-conduct-course/
 Today’s Agenda
 Course Overview (15 mins)
 What is Research?: Types and Design (30
mins)
 Research Ethics (30 mins)
 Ethics Tutorial & Course (5 mins)
 Identifying the Research Question (30 mins)
 Finding the Evidence: Charlotte Beck (30
mins)
 Learning Objectives
 Define and discuss the FINER
characteristics of a “good” research
question
 Appreciate how a theoretical rationale
forms the framework for a research
question
 Define PICO(T) and use it to
operationalize any research question
 Research Process
 Phase I: Identify the research question
 Define the research problem
 Review literature; provide theoretical framework
 Identify target population
 Identify variables
 State research rationale & objectives
 State specific hypotheses
 Phase II: Design the study
 Phase III: Methods
 Phase IV: Data Analysis
 Phase V: Communication (i.e., report findings, suggest future
studies)
 Discussion
 What factors should/would you consider
when developing a clinical research
question?
 Research Question: “FINER”
 Feasible
 Equipment, time, support, money, etc.
 Interesting to the investigator/clinician
 Novel
 Generates knowledge
 Ethical
 Can be studied with no or minimal potential harm
to participants
 Relevant clinically/important
 “So what?!” factor
 Research Questions:
Additional Characteristics
 Answerable
 Question can be studied scientifically
 Be void of judgment or philosophical issues
 Variables that can be defined and measured

 Appropriate stage of evaluation

 Prevention: Need research to identify risk
factors prior to conducting intervention trials to
examine efficacy/effectiveness
Research Cycle
 Research Questions
 Importantly, one must accept that only one
small (but hopefully important) facet of a
problem can be addressed in a single
study
Research Question Development

Theoretical
Framework
 Chapter 2: Role of Theory

Will be covered in RHSC 502: Only be a brief

demonstration in this lecture
 Theoretical Framework &
Research Question
 Theoretical framework = the lens which
one views the problem of interest
 Framework guides the research questions
and ultimately the research methods
 Importance of Theoretical
Frameworks
 Serves as an analogy for the real
phenomenon (e.g., schematic
representation, statistical)
 Structural representation of the concepts
that comprise the theory
 Critical in how you rationalize your
research question, experimental approach,
and research findings/results
 Frameworks Dependent on
Perspective (more on this later)
Acute Injuries……..To Ice or Not?

 Try it….google “to ice or not after acute injuries”….

Acute Injuries……..To Ice or Not?
 Level 2 evidence that
ice does not reduce
swelling
 Does reduce the
perception of pain
 May actually slow down
the healing process
 Paradigm Shift
 A change in the basic framework that
governs the way knowledge is pursued
 Results from continuous research and
collaborative discussions and intellectual
exchange

 Any examples?
 Example: Heart Disease
 What causes coronary heart disease?
a. Diet high in saturated fats
b. Diet high in sugar
 Heart Disease
 The theory of dietary saturated fats as the
principal promoter of elevated serum
cholesterol and heart disease stems from
research beginning in the 1950's by an
American scientist Ancel Keys.
 This theory was embraced by the
American Heart Association and the US
federal government in the 1960s and 70s.
 Heart Disease
 Recent meta-analysis and systemic
reviews which reviewed evidence from
randomized control trials (RCT) that had
been conducted between 2009-2017
did not find an association
between saturated fat intake and the risk
of heart disease.
 Defining your Research
Question
 Sounds easy, but formulation takes time
and thought!
 Using PICO to formulate your question:
 P: People/Population
 I: Intervention
 C: Comparison/Control
 O: Outcome
 Expansion: PICO(T)
 Target Population (among…..)
 Intervention (aka treatment) or Indicator
(exposure; aka risk factor) (does….)
 Comparison (versus…..)
 Outcome (affect…..)
 Time (type of study; prospective, etc.)

 Only a framework, not a rigid model

 Intervention Example
Is “progressive” PT immediately post ACL
reconstruction more effective in improving
knee ROM compared with standard PT?
 P: People with ACL reconstruction
 I: “Progressive” PT
 C: Standard PT
 O: Knee ROM
 Etiology/Risk Factor Example
Does smoking increase the risk of lung
cancer?
 P: Adults aged 55 years and older
 I: Smoked daily for > 10 years
 C: Never smoked
 O: Lung cancer (y/n)
 Screening Example
Is the Lachman ACL Test as “good” as a
MRI in confirming an ACL rupture?
 P: Individuals with probable ACL ruptures
 I: Lachman ACL Test
 C: MRI
 O: Diagnosis of ACL rupture
 Descriptive Example
What are emotions experienced by
individuals who recently had tested a
positive COVID-19 test?
 P: Individuals who tested positive
 I: N/A
 C: N/A
 O: Emotions experience
 Framework & Question
 Topic: ACL ruptures
 Problem: Higher incidence of ACL
ruptures among female athletes than male
athletes
 Broad Question: Why?
ACL Ruptures
 Discussion
 Discuss 1 possible theoretical/conceptual
frameworks that you could “view” or
“frame” this problem
 Develop your research question using the
PICO format
 Research Question: Many
Considerations
 What do we know and what are the gaps in
the literature?
 What study design will address the
knowledge gap?
 Who should be included in the study?
 What is the intervention (if applicable) and
what is its design?
 What (or who) is the control/comparison
group?
 What outcomes will you use (and why)?
Importance of multidisciplinary
perspective!
QUESTIONS?
 Homework:
 Select one recent publication from your
supervisor’s group (answer the following
questions)
1. What is the research question?
2. Is it non-experimental or experimental?
 Report back in class
 Guest: Reference Librarian
Charlotte Beck
[email protected]

Reference Librarian
Woodward Library Woodward Library
2198 Health Sciences Mall
Vancouver, BC
V6T 1Z3
Subject Specialties and Research Guides
Occupational Science and Occupational Therapy
Physical Therapy
Audiology and Speech Sciences
Rehabilitation Sciences
History of Science and Medicine
Done!