Transcript Research and You! Alicia Sloan, MPH, MSW Jim Hunziker, MSN, ARNP

Research and You!
Mike
Alicia Sloan, MPH, MSW
Jim Hunziker, MSN, ARNP
Michael Donahue, BS
Jim
MS Center of Excellence (MSCoE) – West
VA Puget Sound Health Care System
Seattle, Washington
March 8, 2008
Alicia
MSCoE - Background
• MS Centers of Excellence (MSCoE): Funded by the VA in
January 2003 to address health needs of veterans with MS
on a national level.
• MSCoE-East: Baltimore, MD & Washington, DC
• MSCoE –West: Portland, OR & Seattle, WA
• MS research is part of the mission of MSCoE, along with
(1) Clinical Care, (2) Education, and (3) Informatics.
• Who does the research? Interdisciplinary professionals (several
different disciplines) who want to improve health care for people
with MS.
• For example: physicians, nurses, social workers, psychologists,
occupational therapists, physical therapists, etc.
• Each discipline gives a different perspective to enrich research.
Presented by Alicia Sloan, slide 2
MSCoE - Research Focus
• Conduct studies that address special
health care needs of veterans with
MS (not typical in the “civilian”
population of MS):
– Much higher proportion of males
– More disabled
– Higher % of progressive forms of MS
Presented by Alicia Sloan, slide 3
MSCoE - Types of Research
• Pre-clinical & clinical trials: Clinical trial of a new
medication or intervention, or new use or “off-label” use of
existing medication or intervention. Often several
phases/stages of research before FDA-approved.
• Pilot studies: Involves a smaller number of people. May help
decide if it makes sense to do a larger study in the future.
• Multi-site studies: Involves more than one VA site and/or
in collaboration with non-VA site.
• Health services research: Improve quality of patient
services.
• Economics research: Improve costs of care for MS.
• Secondary data analysis: Obtain data from existing
databases to answer a question.
Bottom Line: We learn from you and your health experiences!
Presented by Alicia Sloan, slide 4
MSCOE – Current Research
National MS Data Repository:
– What is it? Began as a MS needs assessment study that
developed into a large database. Links to other VA databases
now. A rich database about veterans with MS. Researchers
apply to obtain data to answer a question about veterans with
MS.
– Investigator Studies: Exercise, obesity, pain, pulmonary
(lung), kidney stones, spasticity, tobacco use, immunizations,
ER use, VA costs.
– Large Study: Data Validation of the Repository – Confirming
the data in the repository is accurate.
Bottom Line: Data Repository helps us to answer questions
about health problems of veterans with MS and
develop
future research and health interventions to
address
the problems.
Presented by Alicia Sloan, slide 5
MSCOE – Current Studies
 Specialty Care: Examining MS-specific care
appointments & cost
 Home Telehealth: An intervention to improve access to
care and improve quality of care for veterans with
chronic care needs using a home telehealth monitor.
 MS Core Question Set (national home telehealth
program)
 DMT Adherence (health behavior change)
 Stroke Robotics Trial – May inform future MS robotics
clinical trials for upper extremity rehab; “piggy-back”
studies.
Presented by Alicia Sloan, slide 6
MSCOE – Current Studies (cont.)
 Gulf War study with MSCoE–East – Using VA and
other DOD databases. Study is a result of concern
for US veterans deployed to the 1990-1991 Gulf War
(GW) may be at increased risk in developing neurologic
disease. Potentially controversial.
 Medical Residents/PhD Students – Provider Attitudes
for End of Life Care for MS, Obesity, Nursing
Telehomecare, Medical Ethics, Spasticity,
Kidney Stones, and ER-use.
Presented by Alicia Sloan, slide 7
MSCOE – Future Studies
– Home Telehealth & Exercise – health
behavior change to improve fatigue and
cognition.
– Ginkgo biloba - clinical trial with
Portland VA to improve fatigue and
memory.
Presented by Alicia Sloan, slide 8
MS Research: How do I participate?
• You might receive a letter announcing a MS
study
• You might see flyers or posters about a study
• You might be approached in MS clinic
• Check VA MSCoE website: http://www.va.gov/ms
• Check other MS organizations’ websites, eg:
www.nationalmssociety.org/
www.mscare.org/cmsc
www.msaa.com
www.msfocus.org
Check with your local university or college website
Presented by Alicia Sloan, slide 9
MSCOE – Research Results
• Published in MS Professional journals.
• Published in Patient centered journal articles.
• Published in MSCoE website articles:
http://www.va.gov/ms/
• Presentations at national conferences to share
knowledge with other MS professionals.
• Published in VA newsletters, video
teleconferences, telephone conference calls.
• Published on websites of MS organizations.
Presented by Alicia Sloan, slide 10
SO, WHAT IS RESEARCH
ALL ABOUT, ANYWAY?
• A way of increasing our
understanding of how and why our
bodies behave the way they do!!
Presented by James Hunziker, slide 11
OVERVIEW
•
•
•
•
•
What Research Is and Isn’t
A Model of Scientific Inquiry
Different Types of Research
What Method to Use When
Applied and Basic Research
Presented by James Hunziker, slide 12
Why do we do
research?
• Most Medical Practice is based on
practices that have always been done
(80% or so)
• As a result of research, more
practice is being based on methods
that we now know are correct
• Research is how the “Best Practices”
are determined
Presented by James Hunziker, slide 13
An example
• A good example of this is: What is
the best way to take a temperature?
• There are many choices:
–
–
–
–
–
Orally
Rectally
Underarm
Tympanic (ear)
Forehead
Presented by James Hunziker, slide 14
Taking a Temperature,
continued…
• Each method has it’s drawbacks
• Many treatments are (partially)
based on whether a person has a
fever, and if so, how high the
temperature is
Presented by James Hunziker, slide 15
Taking a Temperature Findings
• Research has shown that
– Tympanic and/or Rectal temperatures are the
most accurate (who wants a thermometer put
in their rectum?)
– Oral temperatures are good as long as nothing
has been taken orally for at least 30 minutes
– Underarm is not very accurate, but must be
used in some situations
– Forehead temperatures work for children as a
screening tool, but are less accurate
than oral/tympanic
Presented by James Hunziker, slide 16
Another question that has
been looked at is
• What is the best way to treat a pressure
ulcer?
–
–
–
–
–
Massage?
Sugar?
Wet-to-dry dressings?
Hydrocolloids?
Dry dressings?
• Research was used to demonstrate what
was best, what should be avoided
Presented by James Hunziker, slide 17
What are the Research
methods?
• A THEORY of why something happens
is developed
• This theory helps by
– Organizing the information there is
about the problem/issue/medication
– Explains past findings
– Predicts or validates new or current use
Presented by James Hunziker, slide 18
RESEARCH IS BASED ON
THE WORK OF OTHERS
• Past research or findings helps guide
new research
• Research does NOT copy the work of
others, but
• Expands on what others have done
Presented by James Hunziker, slide 19
To be valid, Research findings
can be repeated by others
• Repeatability is a sign of credible
science
• Replication guides future research
Presented by James Hunziker, slide 20
RESEARCH IS
GENERALIZABLE
• Research should apply to situations
outside of the study setting (i.e.
general life/living)
Presented by James Hunziker, slide 21
RESEARCH IS NOT DONE
IN INTELLECTUAL
ISOLATION
• For example:
• It is done as a result of a question being
raised
• It is based on some logical rationale
• It is tied to a theory of why something
should be
Presented by James Hunziker, slide 22
RESEARCH IS
“DOABLE”
• Good research questions can be
translated into projects that can be
done!
Presented by James Hunziker, slide 23
RESEARCH IS
ONGOING
• Research generates new questions
• Research is incremental
• A question is asked, then after
approval researched
• Based on the answers from the
previous study, new research
questions are asked
Presented by James Hunziker, slide 24
The steps of the research process:
Presented by James Hunziker, slide 25
Steps of the Research
process continued.
• Refer to slide 24
Presented by James Hunziker, slide 26
The first item in doing
research is to
• Ask or develop the right question
to ask,
• Identify a need
• Have a medication or product that
needs to be tested
Presented by James Hunziker, slide 27
IDENTIFYING IMPORTANT
FACTORS
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•
•
•
•
Not fully investigated
Advance understanding
Can be investigated
Are interesting
Lead to more questions
Presented by James Hunziker, slide 28
A HYPOTHESIS IS
FORMULATED
• “If…then” statements
• Objective extension of the original
question
• In a testable form
Presented by James Hunziker, slide 29
Decide on Research Method
• There are many research methods
that can be used. Here are some:
– Experimental, true Experimental, or
Non-experimental Research
– Applied vs. Basic research
– Descriptive research
– Historical research
Presented by James Hunziker, slide 30
Which research method
to use is determined by
• Nature of question asked
• Method used to answer question
• Degree of precision of method
Presented by James Hunziker, slide 31
RELEVANT INFORMATION
IS COLLECTED
• Hypotheses posit a relationship
between different factors
• Data are collected that will
confirm or refute the hypothesis
• Hypotheses are testable (not
provable)
Presented by James Hunziker, slide 32
HYPOTHESIS MUST BE
TESTED
• Inferential statistics
– Separate effects of factors from
effects of chance
– Assign a probability level to obtained
data
Presented by James Hunziker, slide 33
THE HYPOTHESIS IS
WORKED WITH
• If the hypothesis is confirmed
– Plan new research
• If the hypothesis is refuted
– Try to understand what other factors
might be important
Presented by James Hunziker, slide 34
Depending on what is
found, the theory may
need to be reconsidered
• Theories can be modified
• Leading to new questions
Presented by James Hunziker, slide 35
Participating in Research:
What you should know
Presented by Michael Donahue, slide 36
Participating in Research:
What you should know
• There are regulations in place to help
protect people who participate in
research
• Studies are approved by local ethics
boards and agencies such as Food and
Drug Administration (FDA) and the
National Institutes of Health (NIH)
Presented by Michael Donahue, slide 37
Participating in Research:
What you should know
• These approvals mean they believe the
research is scientifically valid, and
• based on the available information, risks
are minimized and worth the potential
benefit.
Presented by Michael Donahue, slide 38
Participating in Research:
What you should know
• These approvals do not mean:
– there aren’t risks involved
– you will benefit
– the study is right for you
Presented by Michael Donahue, slide 39
Presented by Michael Donahue, slide 40
Participating in Research:
Questions to Ask
• Why is the research being done?
• Why do they think this treatment might
be effective?
• What kind of tests will you have?
• What are the risks?
Presented by Michael Donahue, slide 41
Participating in Research:
Questions to Ask (cont.)
• How do the risks compare to the
risks of standard treatments?
• How much time is involved (hours,
number of visits, days of the week)?
• Will it cost anything?
• How will your privacy be maintained?
Presented by Michael Donahue, slide 42
Participating in Research:
What You Should Know
• You have the right to withdraw at
any time.
• Ask questions if you don’t understand
something!
• Try to read the consent form in
advance of the appointment.
Presented by Michael Donahue, slide 43
Final Words
Can you benefit from
participating in a research
study? Absolutely!
Are there risks! Yes!
Only you can decide if it’s right for you!
Presented by Michael Donahue, slide 44
Presented by Michael Donahue, slide 45
For more information on
research:
• www.clinicaltrials.gov
• VA’s MSCoE website: www.va.gov/ms
• Non-VA MS organizations:
www.nationalmssociety.org/
www.mscare.org/cmsc
www.msaa.com
www.msfocus.org
Presented by Michael Donahue, slide 46