research and you! alicia sloan, mph, msw jim hunziker, msn, arnp michael donahue, bs ms center of...

Research and You! Research and You! Research and You! Research and You! Alicia Sloan, MPH, MSWAlicia Sloan, MPH, MSW

Jim Hunziker, MSN, ARNPJim Hunziker, MSN, ARNPMichael Donahue, BSMichael Donahue, BS

MS Center of Excellence (MSCoE) – WestMS Center of Excellence (MSCoE) – WestVA Puget Sound Health Care SystemVA Puget Sound Health Care System

Seattle, WashingtonSeattle, Washington

March 8, 2008March 8, 2008

Jim

Mike

Alicia

• 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.

MSCoE - Background

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


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!


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.

MSCOE – Current Research


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.

MSCOE – Current Studies


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.

MSCOE – Current Studies (cont.)


– Home Telehealth & Exercise – health behavior change to improve fatigue and cognition.

– Ginkgo biloba - clinical trial with Portland VA to improve fatigue and memory.

MSCOE – Future Studies


• 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/cmscwww.msaa.com www.msfocus.org

Check with your local university or college website

MS Research: How do I participate?


• 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.

MSCOE – Research Results


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


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


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


• 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


Taking a Temperature, continued…

• 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


Taking a Temperature Findings

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


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


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


To be valid, Research findings can be repeated by

others

• Repeatability is a sign of credible science

• Replication guides future research


RESEARCH IS GENERALIZABLE

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


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


RESEARCH IS “DOABLE”

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


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


The steps of the research process:


• Refer to slide 24


Steps of the Research process continued.

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


IDENTIFYING IMPORTANT FACTORS

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


A HYPOTHESIS IS FORMULATED

• “If…then” statements• Objective extension of the original

question• In a testable form


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


Which research method to use is determined by

• Nature of question asked• Method used to answer question• Degree of precision of method


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)


HYPOTHESIS MUST BE TESTED

• Inferential statistics – Separate effects of factors from

effects of chance– Assign a probability level to obtained

data


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


Depending on what is found, the theory may

need to be reconsidered

• Theories can be modified• Leading to new questions


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)



• These approvals mean they believe the research is scientifically valid, and

• based on the available information, risks are minimized and worth the potential benefit.



• These approvals do not mean:– there aren’t risks involved– you will benefit– the study is right for you


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?


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?


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.


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!


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.comwww.msfocus.org


research and you! alicia sloan, mph, msw jim hunziker, msn, arnp michael donahue, bs ms center of...

Documents

wa ms research

mscoe current research

clinical care

health services research

future research

national ms data repository

ms centers of excellence

alicia sloan