Statistical modeling in pharmaceutical research and development.
Hlten514 b research
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HLTEN514B
Apply Research Skills Within a
Contemporary Health Environment
www.tastafe.tas.edu.au
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Topic 1 – An Overview
What is research?
Where does knowledge come from?
Language of research
Types of research
Application to practice
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What is Research?
“Systematic process using both inductive
and deductive reasoning to confirm and
refine existing knowledge and to build new
knowledge” (Borbasi, Jackson & Langford, 2004, pp.68)
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Where does knowledge come from?
• Over the years, knowledge has been
gained from many sources
• Some reliable
• Some not so reliable and bring risk
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Sources of Knowledge
Tradition and Custom
- Passed on from generation to generation
- Reflects our culture and heritage
For example: As nurses we provide daily linen changes
and bathing. Why?
We traditionally take patients‟ obs each shift. Why?
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Sources of Knowledge
Authority
- Reliance on individuals as „experts‟
- Information obtained from text books and perhaps
teachers?
How can you ensure this information is correct?
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Sources of Knowledge
Trial and Error
- Uses successive numbers of alternative solutions.
- Often used when we have no reference to draw
upon.
What are the weaknesses of this approach?
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Sources of Knowledge
Personal Experience
- First-hand knowledge
- Often hard to translate or explain to others who
have no similar experience.
Novice Advanced Beginner Competent
Proficient Expert
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Sources of Knowledge
Intuition
- „hunch‟ or „gut feeling‟
- Closely tied to personal experience
- Perceptual awareness
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Sources of Knowledge
Reasoning
- Use of logical thought pattern
- Inductive reasoning: starts with facts and builds a larger
picture
- Deductive reasoning: starts with the big picture and
breaks down into smaller parts.
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Why do we need to do it?
– Critical appraisal
– Provide quality care based on facts
– Legal accountability for practice
– Latest & best practice to improve outcomes
– Link theory, education & practice
– Cost effective care
– Improve decision making, prioritising & organising
nursing care
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Evolution of nursing research
1854 Florence Nightingale
implementing sanitary reforms – considered to be
the first nursing study.
Slow start – next research 1940‟s!
60‟s and 70‟s advance degrees increased a push for
PhD
1970‟s two new nursing journals – research explosion!
1980‟s in Aust and NZ – Nursing moved into tertiary
education sector
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Nursing Research
Some examples of nursing research
• Wound Healing
• Pressure relieving devices for ulcers
• Client information
• Nutritional support for elderly
• Urinary incontinence
• Hypothermia in OR
• Pain
And many more
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The Language of Research
• Research has its own language
• Some common terms are explained in the
following slides
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The Language of Research
Efficacy
- The ability of an intervention to produce
beneficial results that it is intended to deliver
within a research study.
www.bidmc.org/YourHealth/HealthResearchJournals.aspx
Abstract
- A brief, comprehensive summary of a study.
(Elliott & Burr, 2000, pp.574)
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The Language of Research
Validity
- Is the research providing answers to the research
questions for which is was undertaken?
- If so, is it providing these answers using appropriate
methods and procedures?
(Kumar, 1996, pp.137)
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The Language of Research
Reliability
- Is the research tool reliable, i.e.
consistent, stable, predictable and accurate?
(Kumar, 1996, p.140)
Bias
- A distortion in the data analysis results.
(Elliott & Burr, 2000, pp. 575)
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The Language of Research
Dissemination
- The communication of research findings. E.g.
publication of research papers, presentations at
conferences etc.
Hypothesis
- A predication about the relationship between two or
more variables.
Variable
- A defined concept
(Elliott & Burr, 2000, pp. 575)
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The Language of Research
• Methodology
• Control
• Randomisation
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Types of Research
There are three main types of research
• Quantitative – objective, about numbers
• Qualitative – subjective, about feelings
and experiences
• Mixed Method – a mixture of both the
above
• Each type has varying methods
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Types of Research
Quantitative
- A systematic process used to gather and statistically
analyse information that has been measured by an
instrument and converted into numerical data.
- Considered by many to be the truest form of research
Qualitative
- Reality is subjective, multifaceted rather than a
single, fixed, objective, actuality.
- Investigates feelings and experiences
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Mixed Method Research
• Combination of quantitative and qualitative date
collection methods
• Seeks to build on the strengths and weakness of
both methods
• Gaining in popularity
• It‟s use is widely debated
(Andrew S, and Halcomb E 2008 “Mixed Method Research” in Borbasi S, Jackson
D and Langford R Navigating the Maze of Nursing Research 2e. Mosby
Elsevier)
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What is Evidence Based
Practice?• Basing (in the case of nursing) clinical
practice, on solid evidence found through
a deliberate collection of research on any
given topic.
• Policy and procedure should be based on
evidence gained through reliable and valid
research, not on trial and error, cultural
practice or any other method through
which knowledge is gained.
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Evidenced Based Practice -
EBP
- Applying the most current research based evidence
in making decisions about patient care.
- Conscientious integration of best research, clinical
expertise, patient values, preferences and needs to
provide quality, cost effective health care.
- Allows a streamlined and structured way of keeping
abreast of new research developments without the
overload.
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Evidenced Based
Practice - EBP
• Clinical
Expertise
• Expert
Panels, Leader
s
Best available Evidence
Patient preferences & values
Evidence Based Clinical
Decision Making
= Practice
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Evidence Based Practice - EBP
• Benefits of EBP
– Patients & consumers
– Nurses
– Health care organisations
– Community
Provide care that is supported by
facts, than myths, rituals or habits
Legally accountable for practice
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Evidence Based Practice
• There are centres that collect, collaborate
and disseminate research findings
• The task is too large for an individual on
many topics
• Facilities then adopt EBP in to policy and
procedure
• Can take many years from research to
changing practice
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Evidence Based Practice - EBP
Five steps to EBP
1. Ask the question
2. Collect best & relevant evidence
3. Critically appraise the evidence
4. Integrate that evidence with clinical
expertise, patient values & preferences in
making change or decisions
5. Evaluate the decisions or change
Melnyk & Fineout-Overholt, 2005, pg 9
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Evidence Based Practice -
EBP
• Evidence can be found
– CINAHL (Cumulative Index to Nursing &
the Allied Health Literature)
– Medline
– The Cochrane Library
– Meditext
– Conference Papers
– Joanna Briggs Institute (JBI)
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How is research utilised in
practice
• Research based policy, procedure and clinical
practice guidelines
Barriers to implementation of EBP
• Resistance to change
• Insufficient time and resources to implement
change to practice
• Lack of supportive infrastructure
• Lack of research skills – inability to critique
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Research and the EN
“a professional nurse
interprets, evaluates and determines
the credibility of research findings
…..(in order to) promote the
integration of research and clinical
practice”.
(Beanland & Scneider, 2000, pp.7)
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Research and the EN
• All nurses must base their practice on the
best available evidence
• ANMC competencies refer to practice
based on evidence
• Requirement of annual PD
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References
(Andrew S, and Halcomb E 2008 “Mixed Method
Research” in Borbasi S, Jackson D and
Langford R Navigating the Maze of Nursing
Research 2e. Mosby Elsevier)
Beanland, C., Schneider, Z., LoBiondo-
Wood, G., Haber, J. (1999). Nursing
Research: Methods, Critical Appraisal and
Utilisation. Artamon: Mosby.
Borbasi, S., Jackson, D., Langford, R. (2004).
Navigating the Maze of Nursing Research.
Marrickville: Mosby.
Burns, N., & Grove, S. (1995). Understanding
Nursing Research. Pennsylvania: W.B.
Saunders Company.
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References
Crotty, M. (1998). The Foundations of
Social Research: Meaning and
Perspective in the Research Process. St
Leonards: Allen & Unwin.
Daly, J., Kellehear, A., Gliksman, M. (1997).
The Public Health Researcher: A
Methodological Guide. South Melbourne:
Oxford University Press.
Elliott, D., & Burr, G. (2000). Study Guide
to Accompany Nursing Research:
Methods, Critical Appraisal and Utilisation.
Marrickville: Mosby.
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References
Kumar, R. (1996). Research Methodology: A
step-by-step guide for beginners. South
Melbourne: Addison Wesley Longman.
Peace, S. (1990). Researching Social
Gerontology: Concepts, Methods and
Issues. SAGE Publications: London.
Punch, K. (1998). Introduction to Social
Research: Quantitative & Qualitative
Approaches. SAGE Publications: London.
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