Research and You!

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Research and You!
Mike

• Alicia Sloan, MPH, MSW
• Jim Hunziker, MSN, ARNP
• Michael Donahue, BS
• MS Center of Excellence (MSCoE) West
• VA Puget Sound Health Care System
• Seattle, Washington
• March 8, 2008

Jim
Alicia
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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
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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
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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
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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
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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
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MSCOE Current Studies (cont.)

• Gulf War study with MSCoEEast 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
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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
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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
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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
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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
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OVERVIEW

• What Research Is and Isnt
• A Model of Scientific Inquiry
• Different Types of Research
• What Method to Use When
• Applied and Basic Research

Presented by James Hunziker, slide 12
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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
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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
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Taking a Temperature, continued

• Each method has its 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
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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
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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
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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
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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
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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
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RESEARCH IS GENERALIZABLE

• Research should apply to situations outside of
  the study setting (i.e. general life/living)

Presented by James Hunziker, slide 21
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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
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RESEARCH IS DOABLE

• Good research questions can be translated into
  projects that can be done!

Presented by James Hunziker, slide 23
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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
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The steps of the research process
Presented by James Hunziker, slide 25
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Steps of the Research process continued.

• Refer to slide 24

Presented by James Hunziker, slide 26
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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
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IDENTIFYING IMPORTANT FACTORS

• Not fully investigated
• Advance understanding
• Can be investigated
• Are interesting
• Lead to more questions

Presented by James Hunziker, slide 28
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A HYPOTHESIS IS FORMULATED

• Ifthen statements
• Objective extension of the original question
• In a testable form

Presented by James Hunziker, slide 29
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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
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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
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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
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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
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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
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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
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Participating in ResearchWhat you should know
Presented by Michael Donahue, slide 36
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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
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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
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Participating in Research What you should know

• These approvals do not mean
• there arent risks involved
• you will benefit
• the study is right for you

Presented by Michael Donahue, slide 39
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Presented by Michael Donahue, slide 40
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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
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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
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Participating in ResearchWhat You Should Know

• You have the right to withdraw at any time.
• Ask questions if you dont understand something!
• Try to read the consent form in advance of the
  appointment.

Presented by Michael Donahue, slide 43
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Final Words

• Can you benefit from participating in a
  research study? Absolutely!
• Are there risks! Yes!

Only you can decide if its right for you!
Presented by Michael Donahue, slide 44
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Presented by Michael Donahue, slide 45
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For more information on research

• www.clinicaltrials.gov
• VAs 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